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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2016/003
Enrollment
377
Registered
2016-01-27
Start date
2016-01-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal behaviour and infant development

Interventions

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

Sponsors

Department of Obstetrics and Gynaecology,
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Neonatal Behaviour Assessment Scores [Neonatal Behaviour Assessment Scores: at first three days, at 2-3 weeks and at 2 months of age ] 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] Exclusive breast feeding rates [At 2 weeks, 2 months and six months ] Rates of respiratory distress requiring intervention [At birth, and then three times daily within the first three days of life until discharge] Occurrence of hyperbilirubinaemia warranting phototherapy (detected clinically and confirmed with serum bilirubin) [Three times daily within the first three days of life until discharge ]

Secondary

MeasureTime frame
None [None]

Countries

Sri Lanka

Contacts

Public ContactProf H.M. Senanayake

Professor

senanayakeh@gmail.comTel: +94 112695300

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026