A randomized controlled trial on the effect of delayed cord clamping and immediate skin to skin contact between mother and baby compared to early cord clamping and early skin to skin contact on neonatal behaviour and infant development

Category Primary study
Registry of TrialsSLCTR
Year 2016
INTERVENTION: The study will be carried out at the University Unit, De Soysa Hospital for Women, Colombo, Sri Lanka. Consenting participants meeting inclusion/exclusion criterial will be allocated into four arms using block randomization The 4 groups are as follows: A. Immediate skin to skin contact and early cord clamping group B. Immediate skin to skin contact and late cord clamping group C. Early skin to skin contact and early cord clamping D. Early skin to skin contact and late cord clamping Definitions Immediate skin to skin contact: contact is within the 1st minute after birth Early skin to skin contact: contact is within 30 minutes of birth. At the end of a period of three minutes of skin contact, the baby will be taken out by the neonatal team by taking the baby in a cephalad direction. The current practice in caesarean sections is for early skin to skin contact with the mother –all babies are breast fed before they leave the theatre. This will be continued in Groups C & D, except that in Group D the baby will be kept on the upper surgical drape or on her lap after drying until clamping of the cord. Early cord clamping will be defined as done immediately (within 90 seconds) after delivery of the baby Late cord clamping will be defined as done after 90 seconds of delivering the baby. The investigators who will assess the outcomes will be blinded to the intervention provided. CONDITION: Neonatal behaviour and infant development PRIMARY OUTCOME: 1. Neonatal Behaviour Assessment Scores; 2. Development scores (raw, scaled and composite) in gross motor, fine motor, expressive speech, receptive speech, cognitive and social / adaptive development assessed via Bayley III infant and toddler scales; 3. Exclusive breast feeding rates ; 4. Rates of respiratory distress requiring intervention; 5. Occurrence of hyperbilirubinaemia warranting phototherapy (detected clinically and confirmed with serum bilirubin); ; INCLUSION CRITERIA: 1. Medically uncomplicated, singleton pregnancies admitted to the Professorial Unit, De Soysa Hospital for Women 2. Rhesus positive mothers 3. Normal antenatal scans 4. Elective caesarean section after a gestation of 37 weeks
Epistemonikos ID: b9322827c035b9e1cba2381c060eaa03ad8d005e
First added on: Aug 24, 2024