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

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776789
• Other study ID #: dranuthukral
• Status: Completed
• Phase: N/A
• First received: October 20, 2008
• Last updated: January 10, 2014
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: January 2014
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
India	AIIMS	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Salivary Cortisol	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).	6 hours	No
Secondary	Breast Feeding Status at 48 Hours	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.	48 hours	No
Secondary	Breast Feeding Status at 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	6 weeks	No