Efficacy and safety of delayed cord clamping versus umbilical cord milking in term neonates

The requested reference [82d93970c79e4fcce78c938a49d6e19b32cc3cca] no longer exists in our database. It has been replaced by the current reference: [56d9ddcde95f8f3c6ab98f999aec162202111372]

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: No previous studies are available which have compared these two interventions in term infants. In order to detect a 30% difference in mean ferritin levels between the delayed cord clamping and umbilical cord milking groups at 3 months of age with a power of 80% and a significance level of 0.05, a total sample size of about 120 infants will be required for the study. Assuming that 20% are lost to follow up, we will recruit a total of 150 infants. Mother‐infant pairs will be randomly allocated to either umbilical cord milking or delayed cord‐clamping group. Allocation will be performed using a computer‐generated list prepared by an independent biostatistician. The random numbers will be generated in 1:1 allocation, without stratification. The list will be kept confidential to primary investigators. The allocation codes will be placed in sequentially numbered opaque and sealed envelopes. The envelopes will be kept in or delivery room in a lock and key cabinet and will be the responsibility of the in‐charge nurse at delivery room. Infants in the cord milking group will be placed at or below the level of the placenta if delivered vaginally or at the same level as the placenta if delivered by cesarean section, and 20cm of the umbilical cord will be actively milked towards the umbilicus three times before clamping the cord. For those randomized to the delayed cord milking, the umbilical cord will be clamped at 60 seconds. A stopwatch in every delivery room will be used to measure the 60 seconds of delayed cord clamping. Follow up will be between 8 and 12 weeks of age . Some of the infants will have their blood drawn at 2 months of age but if they missed the vaccination time (2 months) we allowed them to come back up to 12 weeks (3 months) of age. CONDITION: Infantile‐onset iron deficiency anemia ; Haematological Disorders ; Iron deficiency anaemia, unspecified PRIMARY OUTCOME: Serum ferritin (ng/ml) at 8‐12 weeks of age SECONDARY OUTCOME: 1. Neonatal outcomes:; 1.1. Management in delivery room (right after delivery):; 1.1.1. Cord arterial and venous pH ; 1.1.2. Apgar score at 1 and 5 minutes; 1.1.3. Need for resuscitation beyond suction and gentle simulation ; 1.2. Hematological values:; 1.2.1. Venous Hgb value at 24 h (g/dl); 1.2.2. Venous Hct value at 24 h (%); 1.2.3. Bilirubin level at 24 h (umol/L); 1.2.4. The need for phototherapy during nursery stay ; 1.2.5. Maximum bilirubin level during nursery stay ; 1.2.6. Polycythemia defined as venous Hct > 65% during nursery stay ; 1.2.7. Hgb (g/dl) values at 8‐12 weeks of life ; 1.3. Short‐term outcomes (before discharge from hospital) ; 1.3.1. Admission to NICU; 1.3.2. Respiratory distress syndrome ; ; 2. Maternal outcomes (before discharge from hospital): ; 2.1. Mortality ; 2.2. Estimated blood loss; 2.3. Post‐partum Hgb at 24 h ; 2.4. Need for blood transfusion ; 2.5. Need for manual removal of retained placenta ; 2.6. Length of the 3rd stage INCLUSION CRITERIA: Anticipated full‐term birth at GA > 37 weeks confirmed by US in first trimester or last menstrual period
Epistemonikos ID: 336c64d91f6a728c1a9837186f63162e89df4032
First added on: Aug 24, 2024