BreastfeedingNCT00776789
Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial
A study testing skin to skin contact in people with Breastfeeding, run by All India Institute of Medical Sciences at 1 site in India.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- skin to skin contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Term babies born to mothers by normal vaginal delivery in the study period.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Aims and Objectives
Aim
Read more
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
- Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA)
- Weight at 48 hours as measured by digital infant weighing scale.
- 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.
- Number and duration of feeding sessions till 48 hrs according to the mother as assessed at 48 hours
- 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.
Read the 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
- 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
Outcome Measures:
- Measurement of Breast feeding Behavior at 36-48 hours using Infant Breast feeding Behavior scale
- Salivary Cortisol
- Weight at birth
- Weight at 48 hours
- Number of feeding sessions till 48 hours
- Maternal Perception of Infant activity, feeding and breast milk output.
- Conditions
- Breastfeeding
- Being tested
- skin to skin contact, Control group
- Keywords
- Skin to skin contact, Salivary cortisol, Breast feeding Behavior
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Control groupOther
Also called Conventional care
The infants who were allocated to the conventional care (control group) were kept by the mother's side and did not receive early SSC.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36-48 hours by video recording
Secondary outcomes (3)
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).
Measured: 6 hours
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.
Measured: 48 hours
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anu Thukral, All India Institute of Medical Sciences
- Investigators
- Vinod Kr Paul, MD, Study director, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776789
- Sponsor's protocol ID
- dranuthukral
- Status last verified
- Jan 2014
- First submitted
- 20 Oct 2008
- Last updated
- 27 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22699241
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00776789
- Acronym / sponsor ID
- dranuthukral
- Conditions
- Breastfeeding
- Keywords
- Skin to skin contact, Salivary cortisol, Breast feeding Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Posted 27 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA)
- Weight at 48 hours as measured by digital infant weighing scale.
- 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.
- Number and duration of feeding sessions till 48 hrs according to the mother as assessed at 48 hours
- 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
- 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
Outcome Measures:
- Measurement of Breast feeding Behavior at 36-48 hours using Infant Breast feeding Behavior scale
- Salivary Cortisol
- Weight at birth
- Weight at 48 hours
- Number of feeding sessions till 48 hours
- Maternal Perception of Infant activity, feeding and breast milk output.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skin to skin contact | Experimental | Other: skin to skin contactInfants 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. |
| Control group | Experimental | Other: Control groupThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Term babies born to mothers by normal vaginal delivery in the study period.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin to skin contactInfants 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 | skin to skin contact |
| Control groupAlso: Conventional careThe infants who were allocated to the conventional care (control group) were kept by the mother's side and did not receive early SSC. | Other | Control group |
Primary outcome
The Median Breast Feeding Score
Time frame: 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.
3 secondary outcomes
Salivary Cortisol
Time frame: 6 hours
Breast Feeding Status at 48 Hours
Time frame: 48 hours
Breast Feeding Status at 6 Weeks
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22699241Thukral 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinod Kr Paul, MD study director
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin to skin contact in people with Breastfeeding, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Median Breast Feeding Score (time frame: 36-48 hours by video recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00776789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.