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
Not Applicable
Recruiting
- Conditions
- eonatal behaviour and infant development
- Registration Number
- SLCTR/2016/003
- Lead Sponsor
- Department of Obstetrics and Gynaecology,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 377
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
Exclusion Criteria
1. Babies who do not spontaneously breath within the first 10 seconds of life
2. Babies with a tight nuchal cord, babies with gross congenital anomaly diagnosed at birth
3. Babies with birth weights less than the tenth percentile and babies with hydrops
4. Babies who require resuscitation at birth or require admission to the neonatal unit at birth due to respiratory distress or cyanosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eonatal Behaviour Assessment Scores<br> [Neonatal Behaviour Assessment Scores: at first three days, at 2-3 weeks and at 2 months of age<br>]<br>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 [At 6, 12, 18 and 36 months]<br>Exclusive breast feeding rates [At 2 weeks, 2 months and six months ]<br>Rates of respiratory distress requiring intervention [At birth, and then three times daily within the first three days of life until discharge]<br>Occurrence of hyperbilirubinaemia warranting phototherapy (detected clinically and confirmed with serum bilirubin) [Three times daily within the first three days of life until discharge<br>]<br>
- Secondary Outcome Measures
Name Time Method one [None]<br>