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Kangaroo mother method for low-birthweight infants
The spontaneous abortion rate (excluding chromosomal abnormalities) is 0-4% up to 2 weeks after the procedure and 1% up to week 24 (on the basis of 1800 completed pregnancy reports). We have no evidence of a higher rate of talipes and other defects after early amniocentesis compared with CVS or standard amniocentesis. A randomised study to compare the two procedures could not be done because nearly all patients decided not to take part, choosing amniocentesis rather than CVS because of reports of limb reduction defects. We conclude that early amniocentesis is a safe and efficient alternative to CVS or standard amniocentesis in the hands of a well-trained and
experienced team. B Eiben, B Osthelder, W Hammans, R Goebel Evangelisches
Institut fur Klinische Genetik und Frauenklinik. Oberhausen, 46047 Oberhausen, Germany
1
2
Krankenhaus
Eiben B, Goebel R, Rutt G, Jaspers KD, Hansen S, Hammans W. Die Frühamniocentese zwischen der 12-14. Schwangerschaftswoche. Geburtshilfe Frauenheilkunde 1993; 53: 554-58. Eiben B, Goebel R, Hansen S, Hammans W. Early amniocentesis: a cytogenetic evaluation of over 1500 cases. Prenat Diagn 1994; 14: 497-501.
Kangaroo mother method for low-birthweight infants colleagues’ main conclusion (Sept 17, p believe, that a large proportion of stabilised low782) is, birthweight (LBW) infants in developing countries can be safely discharged from hospital and cared for at home with the kangaroo mother method (KMM). The report is, to our knowledge, the first of a randomised trial comparing the SiR-Sloan and we
effectiveness of the KMM and of conventional care for LBW infants. This study is important because it again raised interest in KMM as a comprehensive strategy for newborn care. This method has been regarded as one of the methods for thermal control of the newborn, together with incubators, hot-water mattresses, and radiant heaters.’ Originally, however, the KMM was presented as a strategy for newborn carealthough scientific evidence of its effectiveness was lacking; this absence induced scepticism in many developing countries and hampered widespread application of the method. The results of Sloan’s study should help to overcome these doubts: the implementation of the KMM will not result in excess mortality, will reduce the cost of hospital care, and will lessen dependency on sophisticated equipment, electricity, oxygen, and highly trained staff, which are commodities that are becoming scarce in many small and large hospitals in developing countries. The KMM will also increase maternal-infant bonding and parental concern for the health of the baby, while reducing the risks deriving from improper use and maintenance of incubators.4 The study deserves the follow-up proposed by Sloan-ie, similar studies in populations in which breastfeeding is less common. Research is also needed on acceptability of the KMM for hospital staff and mothers, since its success depends on good communication, encouragement, and solidarity in the household. In addition, applicability of the KMM should be investigated in hospitals, for the LBW infants who are exposed to a higher mortality risk-ie, those who were not eligible for the study in Ecuador. We are developing a protocol for a multicentre study that will address these issues. With respect to the recorded difference (5% vs 18%) in frequency of serious illness, we find it hard to regard as true, since all babies had the same feeding and growth patterns 1304
(although we are not sure about this, because breastfeeding is not clearly defined and weight gain is not specified), and the same levels of mortality. Sloan and co-workers do not say what proportion of children was excluded from the study after randomisation. Nevertheless, this seems to have because they say that more babies in the conventional than in the KMM group were in incubators after eligibility: this means that some (how many?) babies assigned to KMM presented with serious illness, warranting a return to conventional care. The number of babies excluded and lost to follow-up is an obvious concern for interpretation of the results. With respect to loss to followup, Sloan does not give a clear explanation: the number of babies in the KMM and control groups shown in tables 1 and 2 is not equal to the 140 and 160 initially assigned to the two methods of care. The babies followed up to determine costs (table at bottom of figure 2) are much lower than those assigned to the groups: is this proportion of loss to follow-up applicable also to the morbidity results? Even if the results for frequency of serious illness were true, it is hard to accept the interpretation that the difference was attributable to greater use of preventive health care services. First, this greater use was not statistically significant. Second, we do not know of preventive interventions for LBW infants that would effectively prevent serious illness as defined in this study (acute lower
happened
respiratory tract disease, apnoea, aspiration pneumonia, septicaemia, general infections); only septicaemia could perhaps be prevented by the early treatment of minor eye and skin infections. A true difference in the rate of serious illness is more probably due to unmeasured (or unmeasurable) variables related to the more maternal-infant contact, such as the baby being left alone less often. An alternative explanation for the difference might be the effect of health workers interpreting and recording in a different way (as more serious) episodes of illness in babies seen less often (the control group); observers were apparently aware of the assignment of individual babies to the intervention or the control groups. Adriano Cattaneo, Riccardo Davanzo, Fabio Uxa, Giorgio Tamburlini Bureau for International Health, Istituto per l’lnfanzia, 34137 Trieste,
1 2 3
Italy
WHO 55th World Health Assembly. Child health and development: health of the newborn. Geneva: WHO 1992. Rey ES, Martinez HG. Manejo racional del niño prematuro. In: Curso de medicina fetal. Colombia: Universidad de Bogotà, 1983: 137. Sinclair JC. Skin-to-skin contact. In: Sinclair JC, Bracen MB, eds. Effective care of the newborn infant. Oxford: Oxford University Press, 1992.
4
Colonna F, Uxa F, da Graça AM, de Vonderweld U. The "kangaroomother" method: evaluation of an alternative model for the care of low birth weight newborns in developing countries. Int J Gynecol Obstet
1990, 31: 335-39.
Author’s
reply
SiR-Cattaneo and colleagues find the difference in the recorded frequency of serious illness between kangaroo and control groups difficult to believe because the groups had the same patterns of feeding and growth. Actually, growth was somewhat better in the kangaroo group, with about a 150-200 g increment in weight between the third and sixth month of life and consistent though small increments in head circumference of 0-1-0-2 cm throughout follow-up. These differences were not reported because they were not
statistically significant. There were no exclusions after randomisation. Similar patterns of, and reasons for, loss to follow-up were recorded
in both groups. Although loss to follow-up is an inherent difficulty in all prospective studies, the survival analyses presented take this censorship into account. Adjusted analyses not presented in the report indicate that of preventive health care partly mediated the use effectiveness of the kangaroo method on reduction in serious illness, which continued to be statistically significant after such adjustment. We agree that severity of illness is more affected than is frequency by early recognition, and that maternal-infant bonding might be another explanation for the observed effects. Although the trial was not conducted blind, we carefully monitored the study’s implementation and data collection and believe that recording bias did not occur. Finally, we agree that the method deserves further study. Although the criteria for eligibility in our study might have been a little conservative, ethical dilemmas could arise from their application in a study of hospital born LBW infants exposed to a higher mortality risk. We suggest that a more conservative assessment should be undertaken initially in rural areas where births are generally non-institutional, technology is less available, and infant feeding patterns are more variable.
Nancy L Sloan Population Council, 1 Dag Hammarskjold Plaza, New York, NY 10017, USA
Breastfeeding and complementary commercially prepared weaning foods SiR-We commend Cohen and colleagues (July 30, p 288) promoting exclusive breastfeeding for the first six months of life under conditions in which introduction to contaminated weaning foods could do more harm than good. But some exceptions to this postion need emphasis for a balanced viewpoint to emerge. Their results show that 11% (50/453) of mothers from the study population successfully accomplished the aim of 6 months of exclusive breastfeeding with weekly encouragement and guidance from the investigators. A total of 31% (141/453) were able to
complete the study. When interpreting study results to arrive at workable public health policy recommendations, the first question that can be asked is, why were 69% of primiparous mothers not working outside the home unable to complete the study? Such a low completion rate calls into question the validity of the hypothesis tested. It seems that the main reason (30%) (135/453) for not being able to continue was a return to work or a move from the area. Without knowing how many are left, it is difficult to determine the true percentage of mothers who resumed working but, for the sake of discussion, we will assume 29%. Another 11% (52/453) did not continue or dropped out of the exclusive breastfeeding group for reasons beyond their control-insufficient milk, maternal health, family pressure not to exclusively breastfeed. These
of reasons account for 40% of the hypothesis tested and brings up the next question. What do we tell mothers who cannot breastfeed because they have to return to work, have insufficient milk, for health reasons, or because they have uncooperative family members who interfere with exclusive breastfeeding during the first six months postpartum? Cohen and colleagues’ results clearly support the alternative that position commercially prepared foods can complementary safely help to meet the nutritional needs of most infants whose mothers can only partly breastfeed during the first six months. This message addresses the needs of most mothers who, for whatever two sets
non-conformity with
or do not exclusively breastfeed during the first six months, by reassuring them that their baby’s growth will not be compromised by the use of hygienically prepared and nutritionally appropriate complementary foods. Nutrition status can be compromised in some infants who are exclusively breastfed beyond four months of age. 1,2 Finally, the results of this study can be used to encourage extended breastfeeding with the reassurance that appropriate weaning foods can complement and support the breast-fed infant’s nutritional needs and help maintain normal growth. Gerber advocates the best feeding regimen a mother can provide that will satisfy her individual baby’s nutritional and developmental needs in the context of their culture. The results of this study show equivalent growth between infants exclusively breastfed and those receiving commerciallyprepared complementary foods in addition to breast milk. These data validate the safety, wholesomeness, and nutritional contributions of commercially prepared weaning foods-a reassuring message for all concerned with infant feeding. From a public health standpoint, however, it would surely benefit all mothers, especially at-risk mothers in developing countries, to be trained in the identification and hygienic preparation of suitable weaning foods from indigenous foods, as well as in the benefits of exclusive breastfeeding for the first six months. Such training will benefit not only those who can follow this recommendation and whose babies do not need the nutritional complements provided by appropriate weaning foods but also the babies who may need complementary foods before six months of
reasons, cannot
age. Sandra J
Bartholmey
Gerber Products
1
Company, Fremont, MI 49413, USA
Chandra RK. Breast-feeding, growth and morbidity. Nutr Res 1981; 1: 25-31.
2
Allen LH. The need for a "life-stage" approach interventions. SCN News 1993; 9: 33-34.
to
micronutrient
Intravenous iron-sucrose complex to reduce epoetin demand in dialysis patients SiR-Recombinant human erythropoietin (epoetin) is well accepted in the treatment of anaemia in chronic renal failure. A well-tolerated intravenous iron preparation (ferrichydroxide/sucrose complex, Venoferrum) is thought to reduce the demand for epoetin in some anaemic dialysis patients.’-3 In our dialysis unit expenditure on epoetin is high so we decided to measure what effect the use of Venoferrum would have on the use of this agent. We collected data from 34 patients (21 males) with endstage renal disease. 26 patients were on chronic intermittent haemodialysis and the other 8 were on continuous ambulatory peritoneal dialysis (CAPD). All 34 patients were receiving subcutaneous injections of epoetin one, two, or three times weekly for anaemia; the median weekly dose was 5300 IU. Oral iron had not resulted in a significant rise in serum ferritin or had caused unacceptable side-effects. Serum ferritin ranged from 13 to 280 j-tg/L (median 51, normal range 10-120). All patients had an initial cumulative intravenous dose of 1150 mg of Venoferrum, in doses of 50-200 mg, after seven consecutive dialysis sessions. The CAPD patients had the same cumulative dose with repeated injections over a period of up to 8 weeks. 21 patients (62%) subsequently had monthly maintenance doses of 50-200 mg. Adjustment of the epoetin dose was based on frequent combined assessment of clinical and routine laboratory data. 1305
experienced team. B Eiben, B Osthelder, W Hammans, R Goebel Evangelisches
Institut fur Klinische Genetik und Frauenklinik. Oberhausen, 46047 Oberhausen, Germany
1
2
Krankenhaus
Eiben B, Goebel R, Rutt G, Jaspers KD, Hansen S, Hammans W. Die Frühamniocentese zwischen der 12-14. Schwangerschaftswoche. Geburtshilfe Frauenheilkunde 1993; 53: 554-58. Eiben B, Goebel R, Hansen S, Hammans W. Early amniocentesis: a cytogenetic evaluation of over 1500 cases. Prenat Diagn 1994; 14: 497-501.
Kangaroo mother method for low-birthweight infants colleagues’ main conclusion (Sept 17, p believe, that a large proportion of stabilised low782) is, birthweight (LBW) infants in developing countries can be safely discharged from hospital and cared for at home with the kangaroo mother method (KMM). The report is, to our knowledge, the first of a randomised trial comparing the SiR-Sloan and we
effectiveness of the KMM and of conventional care for LBW infants. This study is important because it again raised interest in KMM as a comprehensive strategy for newborn care. This method has been regarded as one of the methods for thermal control of the newborn, together with incubators, hot-water mattresses, and radiant heaters.’ Originally, however, the KMM was presented as a strategy for newborn carealthough scientific evidence of its effectiveness was lacking; this absence induced scepticism in many developing countries and hampered widespread application of the method. The results of Sloan’s study should help to overcome these doubts: the implementation of the KMM will not result in excess mortality, will reduce the cost of hospital care, and will lessen dependency on sophisticated equipment, electricity, oxygen, and highly trained staff, which are commodities that are becoming scarce in many small and large hospitals in developing countries. The KMM will also increase maternal-infant bonding and parental concern for the health of the baby, while reducing the risks deriving from improper use and maintenance of incubators.4 The study deserves the follow-up proposed by Sloan-ie, similar studies in populations in which breastfeeding is less common. Research is also needed on acceptability of the KMM for hospital staff and mothers, since its success depends on good communication, encouragement, and solidarity in the household. In addition, applicability of the KMM should be investigated in hospitals, for the LBW infants who are exposed to a higher mortality risk-ie, those who were not eligible for the study in Ecuador. We are developing a protocol for a multicentre study that will address these issues. With respect to the recorded difference (5% vs 18%) in frequency of serious illness, we find it hard to regard as true, since all babies had the same feeding and growth patterns 1304
(although we are not sure about this, because breastfeeding is not clearly defined and weight gain is not specified), and the same levels of mortality. Sloan and co-workers do not say what proportion of children was excluded from the study after randomisation. Nevertheless, this seems to have because they say that more babies in the conventional than in the KMM group were in incubators after eligibility: this means that some (how many?) babies assigned to KMM presented with serious illness, warranting a return to conventional care. The number of babies excluded and lost to follow-up is an obvious concern for interpretation of the results. With respect to loss to followup, Sloan does not give a clear explanation: the number of babies in the KMM and control groups shown in tables 1 and 2 is not equal to the 140 and 160 initially assigned to the two methods of care. The babies followed up to determine costs (table at bottom of figure 2) are much lower than those assigned to the groups: is this proportion of loss to follow-up applicable also to the morbidity results? Even if the results for frequency of serious illness were true, it is hard to accept the interpretation that the difference was attributable to greater use of preventive health care services. First, this greater use was not statistically significant. Second, we do not know of preventive interventions for LBW infants that would effectively prevent serious illness as defined in this study (acute lower
happened
respiratory tract disease, apnoea, aspiration pneumonia, septicaemia, general infections); only septicaemia could perhaps be prevented by the early treatment of minor eye and skin infections. A true difference in the rate of serious illness is more probably due to unmeasured (or unmeasurable) variables related to the more maternal-infant contact, such as the baby being left alone less often. An alternative explanation for the difference might be the effect of health workers interpreting and recording in a different way (as more serious) episodes of illness in babies seen less often (the control group); observers were apparently aware of the assignment of individual babies to the intervention or the control groups. Adriano Cattaneo, Riccardo Davanzo, Fabio Uxa, Giorgio Tamburlini Bureau for International Health, Istituto per l’lnfanzia, 34137 Trieste,
1 2 3
Italy
WHO 55th World Health Assembly. Child health and development: health of the newborn. Geneva: WHO 1992. Rey ES, Martinez HG. Manejo racional del niño prematuro. In: Curso de medicina fetal. Colombia: Universidad de Bogotà, 1983: 137. Sinclair JC. Skin-to-skin contact. In: Sinclair JC, Bracen MB, eds. Effective care of the newborn infant. Oxford: Oxford University Press, 1992.
4
Colonna F, Uxa F, da Graça AM, de Vonderweld U. The "kangaroomother" method: evaluation of an alternative model for the care of low birth weight newborns in developing countries. Int J Gynecol Obstet
1990, 31: 335-39.
Author’s
reply
SiR-Cattaneo and colleagues find the difference in the recorded frequency of serious illness between kangaroo and control groups difficult to believe because the groups had the same patterns of feeding and growth. Actually, growth was somewhat better in the kangaroo group, with about a 150-200 g increment in weight between the third and sixth month of life and consistent though small increments in head circumference of 0-1-0-2 cm throughout follow-up. These differences were not reported because they were not
statistically significant. There were no exclusions after randomisation. Similar patterns of, and reasons for, loss to follow-up were recorded
in both groups. Although loss to follow-up is an inherent difficulty in all prospective studies, the survival analyses presented take this censorship into account. Adjusted analyses not presented in the report indicate that of preventive health care partly mediated the use effectiveness of the kangaroo method on reduction in serious illness, which continued to be statistically significant after such adjustment. We agree that severity of illness is more affected than is frequency by early recognition, and that maternal-infant bonding might be another explanation for the observed effects. Although the trial was not conducted blind, we carefully monitored the study’s implementation and data collection and believe that recording bias did not occur. Finally, we agree that the method deserves further study. Although the criteria for eligibility in our study might have been a little conservative, ethical dilemmas could arise from their application in a study of hospital born LBW infants exposed to a higher mortality risk. We suggest that a more conservative assessment should be undertaken initially in rural areas where births are generally non-institutional, technology is less available, and infant feeding patterns are more variable.
Nancy L Sloan Population Council, 1 Dag Hammarskjold Plaza, New York, NY 10017, USA
Breastfeeding and complementary commercially prepared weaning foods SiR-We commend Cohen and colleagues (July 30, p 288) promoting exclusive breastfeeding for the first six months of life under conditions in which introduction to contaminated weaning foods could do more harm than good. But some exceptions to this postion need emphasis for a balanced viewpoint to emerge. Their results show that 11% (50/453) of mothers from the study population successfully accomplished the aim of 6 months of exclusive breastfeeding with weekly encouragement and guidance from the investigators. A total of 31% (141/453) were able to
complete the study. When interpreting study results to arrive at workable public health policy recommendations, the first question that can be asked is, why were 69% of primiparous mothers not working outside the home unable to complete the study? Such a low completion rate calls into question the validity of the hypothesis tested. It seems that the main reason (30%) (135/453) for not being able to continue was a return to work or a move from the area. Without knowing how many are left, it is difficult to determine the true percentage of mothers who resumed working but, for the sake of discussion, we will assume 29%. Another 11% (52/453) did not continue or dropped out of the exclusive breastfeeding group for reasons beyond their control-insufficient milk, maternal health, family pressure not to exclusively breastfeed. These
of reasons account for 40% of the hypothesis tested and brings up the next question. What do we tell mothers who cannot breastfeed because they have to return to work, have insufficient milk, for health reasons, or because they have uncooperative family members who interfere with exclusive breastfeeding during the first six months postpartum? Cohen and colleagues’ results clearly support the alternative that position commercially prepared foods can complementary safely help to meet the nutritional needs of most infants whose mothers can only partly breastfeed during the first six months. This message addresses the needs of most mothers who, for whatever two sets
non-conformity with
or do not exclusively breastfeed during the first six months, by reassuring them that their baby’s growth will not be compromised by the use of hygienically prepared and nutritionally appropriate complementary foods. Nutrition status can be compromised in some infants who are exclusively breastfed beyond four months of age. 1,2 Finally, the results of this study can be used to encourage extended breastfeeding with the reassurance that appropriate weaning foods can complement and support the breast-fed infant’s nutritional needs and help maintain normal growth. Gerber advocates the best feeding regimen a mother can provide that will satisfy her individual baby’s nutritional and developmental needs in the context of their culture. The results of this study show equivalent growth between infants exclusively breastfed and those receiving commerciallyprepared complementary foods in addition to breast milk. These data validate the safety, wholesomeness, and nutritional contributions of commercially prepared weaning foods-a reassuring message for all concerned with infant feeding. From a public health standpoint, however, it would surely benefit all mothers, especially at-risk mothers in developing countries, to be trained in the identification and hygienic preparation of suitable weaning foods from indigenous foods, as well as in the benefits of exclusive breastfeeding for the first six months. Such training will benefit not only those who can follow this recommendation and whose babies do not need the nutritional complements provided by appropriate weaning foods but also the babies who may need complementary foods before six months of
reasons, cannot
age. Sandra J
Bartholmey
Gerber Products
1
Company, Fremont, MI 49413, USA
Chandra RK. Breast-feeding, growth and morbidity. Nutr Res 1981; 1: 25-31.
2
Allen LH. The need for a "life-stage" approach interventions. SCN News 1993; 9: 33-34.
to
micronutrient
Intravenous iron-sucrose complex to reduce epoetin demand in dialysis patients SiR-Recombinant human erythropoietin (epoetin) is well accepted in the treatment of anaemia in chronic renal failure. A well-tolerated intravenous iron preparation (ferrichydroxide/sucrose complex, Venoferrum) is thought to reduce the demand for epoetin in some anaemic dialysis patients.’-3 In our dialysis unit expenditure on epoetin is high so we decided to measure what effect the use of Venoferrum would have on the use of this agent. We collected data from 34 patients (21 males) with endstage renal disease. 26 patients were on chronic intermittent haemodialysis and the other 8 were on continuous ambulatory peritoneal dialysis (CAPD). All 34 patients were receiving subcutaneous injections of epoetin one, two, or three times weekly for anaemia; the median weekly dose was 5300 IU. Oral iron had not resulted in a significant rise in serum ferritin or had caused unacceptable side-effects. Serum ferritin ranged from 13 to 280 j-tg/L (median 51, normal range 10-120). All patients had an initial cumulative intravenous dose of 1150 mg of Venoferrum, in doses of 50-200 mg, after seven consecutive dialysis sessions. The CAPD patients had the same cumulative dose with repeated injections over a period of up to 8 weeks. 21 patients (62%) subsequently had monthly maintenance doses of 50-200 mg. Adjustment of the epoetin dose was based on frequent combined assessment of clinical and routine laboratory data. 1305