NCT00776789

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. 1.Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA)
  2. 2.Weight at 48 hours as measured by digital infant weighing scale.
  3. 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. 4.Number and duration of feeding sessions till 48 hrs according to the mother as assessed at 48 hours
  5. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

February 27, 2014

Completed
Last Updated

February 27, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

October 20, 2008

Results QC Date

June 1, 2010

Last Update Submit

January 10, 2014

Conditions

Breastfeeding

Keywords

Skin to skin contactSalivary cortisolBreast feeding Behavior

Outcome Measures

Primary Outcomes (1)

  • The Median Breast Feeding Score

    This was a one point assessment done at 36-48 hours by video recording. The video recording was carried out in a separate well lighted room after taking informed consent from the mother. The mother had full right to see the video and only if she was satisfied, was then the video finally stored. These videos were analyzed later using the infant breast feeding assessment tool : a scoring measure \[0 to 3\] for i) readiness to feed ii) sucking iii) rooting and iv) latching. The total possible score could vary from 0 to 12, with 12 being the best possible total score. Successful breastfeeding was defined as a total score of more \>=8.

    36-48 hours by video recording

Secondary Outcomes (3)

  • Salivary Cortisol

    6 hours

  • Breast Feeding Status at 48 Hours

    48 hours

  • Breast Feeding Status at 6 Weeks

    6 weeks

Study Arms (2)

skin to skin contact

EXPERIMENTAL

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.

Other: skin to skin contact

Control group

EXPERIMENTAL

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.

Other: Control group

Interventions

skin to skin contactOTHER

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.

skin to skin contact
Control groupOTHER

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

Also known as: Conventional care
Control group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIIMS

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (1)

  • 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.

    PMID: 22699241DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Limitations and Caveats

This study evaluated breast feeding behaviour of term neonates with only one video, which may not have been an accurate marker of feeding behavior.There could a possibility of inadvertent bias at the time of intervention.

Results Point of Contact

Title
Dr Anu Thukral
Organization
AIIMS
dranuthukral@yahoo.com
01126594605

Study Officials

  • Vinod Kr Paul, MD

    All India Institute of Medical Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 20, 2008

First Posted

October 21, 2008

Study Start

August 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 27, 2014

Results First Posted

February 27, 2014

Record last verified: 2014-01

Locations

IN(1)