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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
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
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
Small for dates and large for dates babies
Infants of diabetic mother
Maternal refusal of consent
Outcome Measures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| skin to skin contact | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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
Small for dates and large for dates babies
Infants of diabetic mother
Maternal refusal of consent.
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| Name | Affiliation | Role |
|---|---|---|
| Vinod Kr Paul, MD | All India Institute of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIIMS | New Delhi | National Capital Territory of Delhi | 110029 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22699241 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Skin to Skin Contact | Babies in this arm will be given skin to skin contact for at least 2 hours after birth |
| FG001 | Control Group | baby will be kept by the mothers side and not given skin to skin contact |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Skin to Skin Contact | Babies in this arm will be given skin to skin contact for at least 2 hours after birth |
| BG001 | Control Group | baby will be kept by the mothers side and not given skin to skin contact |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | scores | 36-48 hours by video recording |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Skin to Skin Contact | Babies in this arm will be given skin to skin contact for at least 2 hours after birth |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Anu Thukral | AIIMS | 01126594605 | dranuthukral@yahoo.com |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Other | The infants who were allocated to the conventional care (control group) were kept by the mother's side and did not receive early SSC. |
|
|
| 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. | 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 | 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | gestation age in weeks | Mean | Standard Deviation | weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Control Group |
Baby will be kept by the mothers side and not given skin to skin contact |
|
|
| 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). | Posted | Median | Inter-Quartile Range | microgram/dl | 6 hours |
|
|
|
|
| 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. | 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. | Posted | Number | percentage of partcipants | 48 hours |
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|
|
|
| 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 | Posted | Number | percentage of partcipants | 6 weeks |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control Group | baby will be kept by the mothers side and not given skin to skin contact | 0 | 21 | 0 | 21 |
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| D008722 | Methods |