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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anu Thukral, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00776789
First received: October 20, 2008
Last updated: January 10, 2014
Last verified: January 2014

October 20, 2008
January 10, 2014
August 2008
June 2009   (final data collection date for primary outcome measure)
The Median Breast Feeding Score [ Time Frame: 36-48 hours by video recording ] [ Designated as safety issue: No ]
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.
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 by video recording. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00776789 on ClinicalTrials.gov Archive Site
  • Salivary Cortisol [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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).
  • Breast Feeding Status at 48 Hours [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.
  • Breast Feeding Status at 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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
Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial
Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breastfeeding
  • 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.
    Other Name: Skin to skin contact
  • 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.
    Other Name: Conventional care
  • Experimental: 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.
    Intervention: Other: skin to skin contact
  • Experimental: 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.
    Intervention: Other: Control group
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00776789
dranuthukral
No
Anu Thukral, All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
Not Provided
Study Director: Vinod Kr Paul, MD All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP