Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial

NCT ID: NCT00776789

Last Updated: 2014-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-06-30

Brief 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.

Detailed Description

Inclusion and exclusion criteria for the enrollment of subjects in the study

Inclusion criteria Term babies born to mothers by normal vaginal delivery in the study period.

Exclusion criteria

1. Babies with major congenital malformation.

2. Multiple pregnancy

3. Babies requiring resuscitation beyond the initial steps

4. Babies requiring care in the neonatal intensive care unit.

5. 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.

6. Small for dates and large for dates babies

7. Infants of diabetic mother

8. Maternal refusal of consent

Outcome Measures:

1. Measurement of Breast feeding Behavior at 36-48 hours using Infant Breast feeding Behavior scale

2. Salivary Cortisol

3. Weight at birth

4. Weight at 48 hours

5. Number of feeding sessions till 48 hours

6. Maternal Perception of Infant activity, feeding and breast milk output.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

skin to skin contact

Infants randomized to this group were placed prone over the mother's chest immediately after birth. Skin-to-skin contact was continued for the next two hours. Mothers in both the groups received support for initiating breastfeeding, if required. All mothers, regardless of the group allocation, were advised to give exclusive breastfeeding to their infants during the hospital stay. They were discouraged from giving supplemental feeds to their infants unless indicated by the duty registrar. All the mothers were counseled regarding the duration of exclusive breastfeeding at the time of discharge.

Group Type: EXPERIMENTAL

skin to skin contact

Intervention Type: OTHER

Infants randomized to SSC group were placed prone over the mother's chest immediately after birth. Skin-to-skin contact was continued for the next two hours. breastfeeding at the time of discharge.

Control group

The infants who were allocated to the conventional care (control group) were kept by the mother's side and did not receive early SSC. All mothers, regardless of the group allocation, were advised to give exclusive breastfeeding to their infants during the hospital stay. They were discouraged from giving supplemental feeds to their infants unless indicated by the duty registrar. All the mothers were counseled regarding the duration of exclusive breastfeeding at the time of discharge.

Group Type: EXPERIMENTAL

Control group

Intervention Type: OTHER

The infants who were allocated to the conventional care (control group) were kept by the mother's side and did not receive early SSC.

Interventions

skin to skin contact

Infants randomized to SSC group were placed prone over the mother's chest immediately after birth. Skin-to-skin contact was continued for the next two hours. breastfeeding at the time of discharge.

Intervention Type: OTHER

Control group

The infants who were allocated to the conventional care (control group) were kept by the mother's side and did not receive early SSC.

Intervention Type: OTHER

Other Intervention Names

Conventional care

Eligibility Criteria

Inclusion Criteria

• Term babies born to mothers by normal vaginal delivery in the study period.

Exclusion Criteria

1. Babies with major congenital malformation.

2. Multiple pregnancy

3. Babies requiring resuscitation beyond the initial steps

4. Babies requiring care in the neonatal intensive care unit.

5. 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.

6. Small for dates and large for dates babies

7. Infants of diabetic mother

8. Maternal refusal of consent.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Anu Thukral

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vinod Kr Paul, MD

Role: STUDY_DIRECTOR

All India Institute of Medical Sciences

Locations

AIIMS

New Delhi, National Capital Territory of Delhi, India

Countries

India

References

Thukral A, Sankar MJ, Agarwal R, Gupta N, Deorari AK, Paul VK. Early skin-to-skin contact and breast-feeding behavior in term neonates: a randomized controlled trial. Neonatology. 2012;102(2):114-9. doi: 10.1159/000337839. Epub 2012 Jun 14.

Reference Type: DERIVED

PMID: 22699241 (View on PubMed)

Other Identifiers

dranuthukral

Identifier Type: -

Identifier Source: org_study_id