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Umbilical-arterial catheterization in high-risk infants
Volume 86 Number 4
Letters to the Editor
641
Editorial correspondence
"Editorial Correspondence" or letters to the Editor relative to articles published in the JOURNALor to topics of current interest are subject to critical review and to current editorial policy in respect to publication in part or in full.
Umbilical-arterial catheterization in high-risk infants To the Editor: As a pediatrician and a new mother, I was shocked to see the article on "Direct Monitoring of arterial blood pressure in depressed and normal newborn infants . . . . ,,11 cannot believe any mother would give informed consent for umbilical artery catheterization. What, in fact, were the mothers told about risks versus benefits? S. Jean Emans, M.D. Adolescents' Unit Children's Hospital Medical Center 300 Longwood Ave. Boston, Mass. 02115
REFERENCE 1. Modanlou H, Yeh S-Y, Siassi B, and Hon EH: Direct monitoring of arterial blood pressure in depressed and normal newborn infants during the first hour of life, J PEDIATR85:553, 1974.
To the Editor: In November, 1973, THE JOURNALOF PEDIATRICSprinted its editorial policy with respect to research employing human subjects. This stated, "THE JOURNALdoes not condone the use of children in investigations in which risks to the subject are high and from which little benefit, either to the subject or to mankind, is gained." It concluded that THE JOURNAL"reserves the right to refuse to publish papers concerning research yielding benefits not justified by the risk. ''t A similar policy statement also appeared in the Archives o f Disease in Childhood. 2 This policy is admirable and to be commended. However, in the October, 1974, issue of THE JOURNAL, Modanlou and associates reported on results of direct blood pressure measurements in depressed and normal newborn infants during the first hour of life. These were measured via urn-
bilical artery catheterization. These children were all products of high-risk pregnancies and this study was done as part of an evaluation of high-risk pregnancy. Out of 150 infants, 115 were judged to be healthy at birth. All 150 infants had umbilical artery catheters insel:ted within the first four minutes of life. An informed consent had been obtained. This catheter was apparently removed at 64 minutes of life. Umbilical artery catheterization is not a benign procedure. Immediate complications include thrombosis, infection, hemorrhage, vasospasm, perforation, and embolization.3' 4 Even in those infants who exhibit no immediate Untoward effects, there may be the possibility of a long-range complication secondary to arterial injury or vascular occlusion. To subject a normal healthy newborn infant, especially one who has managed to successfully withstand a high-risk pregnancy situation, to the hazards of an unnecessary umbilical artery catheterization is unjustified and unethical. The information to be gained was not of sufficient importance to justify the method employed. Indirect methods of blood pressure measurements have been used successfully5 and studies of direct blood pressures have been previously performed.6 The nature of the informed consent is also unclear. Presumably, this was obtained prior to the birth of the infant. I question whether the parents were informed of the Iack of therapeutic benefit from this procedure. This study seems to oppose THE JOURNAL'Seditorial policy and yet was published. Why? Kathleen G. Nelson, M.D. Post-Doctoral Fellow Department o f Pediatrics Yale-New Haven Hospital New Haven, Conn. 06510
REFERENCES 1. The Journal of Pediatrics policy with respect to research employing human subjects, J PEDIATR83:709, 1973. 2. Editorial: The ethics of research involving children as controls, Arch Dis Child 48:751, 1973. 3. Kitterman JA, Phibbs RH, and Tooley WH: Catheterization of umbilical vessels in newborn infants, Pediatr Clin North Am 17:895, 1970.
Letters to the Editor
641
Editorial correspondence
"Editorial Correspondence" or letters to the Editor relative to articles published in the JOURNALor to topics of current interest are subject to critical review and to current editorial policy in respect to publication in part or in full.
Umbilical-arterial catheterization in high-risk infants To the Editor: As a pediatrician and a new mother, I was shocked to see the article on "Direct Monitoring of arterial blood pressure in depressed and normal newborn infants . . . . ,,11 cannot believe any mother would give informed consent for umbilical artery catheterization. What, in fact, were the mothers told about risks versus benefits? S. Jean Emans, M.D. Adolescents' Unit Children's Hospital Medical Center 300 Longwood Ave. Boston, Mass. 02115
REFERENCE 1. Modanlou H, Yeh S-Y, Siassi B, and Hon EH: Direct monitoring of arterial blood pressure in depressed and normal newborn infants during the first hour of life, J PEDIATR85:553, 1974.
To the Editor: In November, 1973, THE JOURNALOF PEDIATRICSprinted its editorial policy with respect to research employing human subjects. This stated, "THE JOURNALdoes not condone the use of children in investigations in which risks to the subject are high and from which little benefit, either to the subject or to mankind, is gained." It concluded that THE JOURNAL"reserves the right to refuse to publish papers concerning research yielding benefits not justified by the risk. ''t A similar policy statement also appeared in the Archives o f Disease in Childhood. 2 This policy is admirable and to be commended. However, in the October, 1974, issue of THE JOURNAL, Modanlou and associates reported on results of direct blood pressure measurements in depressed and normal newborn infants during the first hour of life. These were measured via urn-
bilical artery catheterization. These children were all products of high-risk pregnancies and this study was done as part of an evaluation of high-risk pregnancy. Out of 150 infants, 115 were judged to be healthy at birth. All 150 infants had umbilical artery catheters insel:ted within the first four minutes of life. An informed consent had been obtained. This catheter was apparently removed at 64 minutes of life. Umbilical artery catheterization is not a benign procedure. Immediate complications include thrombosis, infection, hemorrhage, vasospasm, perforation, and embolization.3' 4 Even in those infants who exhibit no immediate Untoward effects, there may be the possibility of a long-range complication secondary to arterial injury or vascular occlusion. To subject a normal healthy newborn infant, especially one who has managed to successfully withstand a high-risk pregnancy situation, to the hazards of an unnecessary umbilical artery catheterization is unjustified and unethical. The information to be gained was not of sufficient importance to justify the method employed. Indirect methods of blood pressure measurements have been used successfully5 and studies of direct blood pressures have been previously performed.6 The nature of the informed consent is also unclear. Presumably, this was obtained prior to the birth of the infant. I question whether the parents were informed of the Iack of therapeutic benefit from this procedure. This study seems to oppose THE JOURNAL'Seditorial policy and yet was published. Why? Kathleen G. Nelson, M.D. Post-Doctoral Fellow Department o f Pediatrics Yale-New Haven Hospital New Haven, Conn. 06510
REFERENCES 1. The Journal of Pediatrics policy with respect to research employing human subjects, J PEDIATR83:709, 1973. 2. Editorial: The ethics of research involving children as controls, Arch Dis Child 48:751, 1973. 3. Kitterman JA, Phibbs RH, and Tooley WH: Catheterization of umbilical vessels in newborn infants, Pediatr Clin North Am 17:895, 1970.