C H Backes1,2,3,4, H Huang1,3, C L Cua2,3, V Garg2,3,5, C V Smith6, H Yin7, M Galantowicz2,3,8, J A Bauer1,3, T M Hoffman2,3. 1. Center for Perinatal Research, Nationwide Children's Hospital, Columbus, OH, USA. 2. The Heart Center, Nationwide Children's Hospital, Columbus, OH, USA. 3. Department of Pediatrics at Nationwide Children's Hospital, Columbus, OH, USA. 4. Department of Obstetrics/Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, USA. 5. Center for Cardiovascular and Pulmonary Research, Nationwide Children's Hospital, Columbus, OH, USA. 6. Center for Developmental Therapeutics, Seattle Children's Research Institute, University of Washington School of Medicine, Seattle, WA, USA. 7. Biostatistics Core at Nationwide Children's Hospital, Columbus, OH, USA. 8. Department of Cardiothoracic Surgery, Nationwide Children's Hospital/The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Abstract
OBJECTIVE:Delayed umbilical cord clamping (DCC) at birth may provide a better neonatal health status than early umbilical cord clamping (ECC). However, the safety and feasibility of DCC in infants with congenital heart disease (CHD) have not been tested. This was a pilot, randomized, controlled trial to establish the safety and feasibility of DCC in neonates with CHD. STUDY DESIGN:Pregnant women admitted >37 weeks gestational age with prenatal diagnosis of critical CHD were enrolled and randomized to ECC or DCC. For ECC, the umbilical cord was clamped <10 s after birth; for DCC, the cord was clamped ~120 s after delivery. RESULTS:Thirty infants were randomized at birth. No differences between the DCC and ECC groups were observed in gestational age at birth or time of surgery. No differences were observed across all safety measures, although a trend for higher peak serum bilirubin levels (9.2±2.2 vs 7.3±3.2 mg dl(-1), P=0.08) in the DCC group than in the ECC group was noted. Although similar at later time points, hematocrits were higher in the DCC than in the ECC infants during the first 72 h of life. The proportion of infants not receiving blood transfusions throughout hospitalization was higher in the DCC than in the ECC infants (43 vs 7%, log-rank test P=0.02). CONCLUSION:DCC in infants with critical CHD appears both safe and feasible, with fewer infants exposed to red blood cell transfusions than with ECC. A more comprehensive appraisal of this practice is warranted.
RCT Entities:
OBJECTIVE: Delayed umbilical cord clamping (DCC) at birth may provide a better neonatal health status than early umbilical cord clamping (ECC). However, the safety and feasibility of DCC in infants with congenital heart disease (CHD) have not been tested. This was a pilot, randomized, controlled trial to establish the safety and feasibility of DCC in neonates with CHD. STUDY DESIGN: Pregnant women admitted >37 weeks gestational age with prenatal diagnosis of critical CHD were enrolled and randomized to ECC or DCC. For ECC, the umbilical cord was clamped <10 s after birth; for DCC, the cord was clamped ~120 s after delivery. RESULTS: Thirty infants were randomized at birth. No differences between the DCC and ECC groups were observed in gestational age at birth or time of surgery. No differences were observed across all safety measures, although a trend for higher peak serum bilirubin levels (9.2±2.2 vs 7.3±3.2 mg dl(-1), P=0.08) in the DCC group than in the ECC group was noted. Although similar at later time points, hematocrits were higher in the DCC than in the ECC infants during the first 72 h of life. The proportion of infants not receiving blood transfusions throughout hospitalization was higher in the DCC than in the ECC infants (43 vs 7%, log-rank test P=0.02). CONCLUSION:DCC in infants with critical CHD appears both safe and feasible, with fewer infants exposed to red blood cell transfusions than with ECC. A more comprehensive appraisal of this practice is warranted.
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