Trial Outcomes & Findings for Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial (NCT NCT00776789)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

36-48 hours by video recording

Results posted on

2014-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Skin to Skin Contact Babies in this arm will be given skin to skin contact for at least 2 hours after birth	Control Group baby will be kept by the mothers side and not given skin to skin contact
Overall Study STARTED	20	21
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Skin to Skin Contact Babies in this arm will be given skin to skin contact for at least 2 hours after birth	Control Group baby will be kept by the mothers side and not given skin to skin contact
Overall Study Consent refusal	2	2
Overall Study Poor quality video	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Skin to Skin Contact n=20 Participants Babies in this arm will be given skin to skin contact for at least 2 hours after birth	Control Group n=21 Participants baby will be kept by the mothers side and not given skin to skin contact	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38 weeks STANDARD_DEVIATION 0.91 • n=5 Participants	38 weeks STANDARD_DEVIATION 1.2 • n=7 Participants	38 weeks STANDARD_DEVIATION 0.98 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36-48 hours by video recording

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.

Outcome measures

Outcome measures
Measure	Skin to Skin Contact n=17 Participants Babies in this arm will be given skin to skin contact for at least 2 hours after birth	Control Group n=18 Participants Baby will be kept by the mothers side and not given skin to skin contact
The Median Breast Feeding Score	8 scores Interval 5.0 to 10.0	9 scores Interval 5.0 to 10.0

SECONDARY outcome

Timeframe: 6 hours

Saliva samples were collected with a Salivette. The infant had to suck on the swab for atleast 5 minutes. The prerequisite for collection of the saliva included that the infant should not have fed atleast 2 hours prior to the collection of the salivary sample. The filtrates were then transferred to a separate tube and were stored at 2-8º C for 24 hours. They were later transported to the central laboratory where the samples were stored at -20ºC and later analyzed using electrochemiluminescence immunoassay (ECLIA).

Outcome measures

Outcome measures
Measure	Skin to Skin Contact n=20 Participants Babies in this arm will be given skin to skin contact for at least 2 hours after birth	Control Group n=21 Participants Baby will be kept by the mothers side and not given skin to skin contact
Salivary Cortisol	0.90 microgram/dl Interval 0.35 to 2.1	0.54 microgram/dl Interval 0.25 to 0.86

SECONDARY outcome

Timeframe: 48 hours

Population: EBF rates were assessed using the standard WHO definitions. We asked the mothers about the method of feeding and the number and amount of supplemental feeds received in the first 2 days of life. Breastfeeding rates at 6 weeks were obtained by enquiring from the mothers at the time of the first vaccination of their infants in the follow-up clinic.

The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases.

Outcome measures

Outcome measures
Measure	Skin to Skin Contact n=20 Participants Babies in this arm will be given skin to skin contact for at least 2 hours after birth	Control Group n=21 Participants Baby will be kept by the mothers side and not given skin to skin contact
Breast Feeding Status at 48 Hours	95 percentage of partcipants	38 percentage of partcipants

SECONDARY outcome

Timeframe: 6 weeks

The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases

Outcome measures

Outcome measures
Measure	Skin to Skin Contact n=20 Participants Babies in this arm will be given skin to skin contact for at least 2 hours after birth	Control Group n=21 Participants Baby will be kept by the mothers side and not given skin to skin contact
Breast Feeding Status at 6 Weeks	90 percentage of partcipants	28 percentage of partcipants

Adverse Events

Skin to Skin Contact

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Anu Thukral

AIIMS

Phone: 01126594605

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place