N/A
N=41
Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial
Breastfeeding
Bottom Line
View on ClinicalTrials.gov: NCT00776789 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: The Median Breast Feeding Score — 8; 9 scores
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- skin to skin contact (Other); Control group (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- All India Institute of Medical Sciences
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Median Breast Feeding Score |
8; 9 | — |
| SECONDARY Salivary Cortisol |
0.90; 0.54 | 0.4 |
| SECONDARY Breast Feeding Status at 48 Hours |
95; 38 | 0.00 sig |
| SECONDARY Breast Feeding Status at 6 Weeks |
90; 28 | 0.001 sig |
Summary
Aims and Objectives
Aim
To determine the effect of delivery room Skin To Skin contact on breast feeding behavior of term neonates born by normal vaginal delivery at 36-48 hours.
Objectives Primary objective To determine the effect of delivery room Skin To Skin contact on breast feeding behaviour of term neonates born by normal vaginal delivery, between 36-48 hours (as measured by Infant Breast Feeding Score) by video recording using a randomized controlled design.
Secondary objectives To determine the effect of delivery room Skin to Skin contact on
1. Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA)
2. Weight at 48 hours as measured by digital infant weighing scale.
3. Maternal perception of breast milk output, breast consistency, infant's feeding and activity at 36-48 hours as measured by a score graded as very satisfied, satisfied, acceptable and not satisfied.
4. Number and duration of feeding sessions till 48 hrs according to the mother as assessed at 48 hours
5. Breast feeding rates at 6 weeks measured at the time of vaccination at the time of visit to the hospital for the same or as asked by telephonic conversation.
Hypothesis
Infants receiving skin to skin contact when compared with neonates not receiving it, demonstrate better breast feeding behaviour.
Eligibility Criteria
Inclusion Criteria
- Term babies born to mothers by normal vaginal delivery in the study period.
Exclusion Criteria
- Babies with major congenital malformation.
- Multiple pregnancy
- Babies requiring resuscitation beyond the initial steps
- Babies requiring care in the neonatal intensive care unit.
- Maternal problems requiring immediate care
- Severe preeclampsia defined as Blood pressure more than 160/110, Proteinuria more than 3+, Oliguria less than 500 ml, Pulmonary edema, cerebral visual disturbances, Impaired liver function, Thrombocytopenia, Epigastric Pain
- Imminent eclampsia
- Severe bleeding
- Mother with significant surgical or medical illness requiring separation of the baby from the mother.
- Small for dates and large for dates babies
- Infants of diabetic mother
- Maternal refusal of consent.
Data sourced from ClinicalTrials.gov (NCT00776789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.