| CTRI Number |
CTRI/2018/09/015632 [Registered on: 06/09/2018] Trial Registered Prospectively |
| Last Modified On: |
06/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of increasing duration of early skin to skin contact on breastfeeding behaviour in healthy neonates. |
|
Scientific Title of Study
|
"Effect of ninety minutes versus sixty minutes of early maternal-newborn skin to skin contact on breastfeeding behaviour and exclusive breastfeeding rate in healthy neonates ≥ 35 weeks of gestation at All India Institute of Medical Sciences, Jodhpur, Rajasthan." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Raj Kumawat |
| Designation |
Post Graduate Student (M.Sc. Nursing) |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
College of Nursing
All India Institute of Medical Sciences
Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9785710003 |
| Fax |
|
| Email |
shalinirajkumawat18031996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Gupta |
| Designation |
Associate Professor (Co Guide) |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Neonatology
All India Institute of Medical Sciences
Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996908 |
| Fax |
|
| Email |
neerajpgi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Himanshu Vyas |
| Designation |
Lecturer (Guide) |
| Affiliation |
All India Institute of Medical Sciences, jodhpur |
| Address |
College of Nursing
All India Institute of Medical Sciences, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003991309 |
| Fax |
|
| Email |
himanshunsg@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur |
|
|
Primary Sponsor
|
| Name |
SHALINI RAJ KUMAWAT |
| Address |
College of Nursing
All India Institute of Medical Sciences, Jodhpur |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SHALINI RAJ KUMAWAT |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR RAJASTHAN |
LABOR ROOM ,BLOCK 1 C
Jodhpur
RAJASTHAN |
9785710003
shalinirajkumawat18031996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS, JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy neonates (equal to or more than)35 weeks of gestation born by vaginal delivery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
60 minutes of early maternal newborn skin to skin contact (Practiced as standard care at AIIMS, Jodhpur) |
Immediately after birth, baby will be placed on mothers bare chest (Skin to skin contact)for 60 minutes and breastfeeding behaviour and exclusive breastfeeding will be assessed at 60 ± 12 hours, 6, 10 and 14 weeks of age of age |
| Intervention |
90 minutes of early maternal-newborn skin to skin contact |
Immediately after birth, baby will be placed on mothers bare chest (Skin to skin contact)for 90 minutes and breastfeeding behaviour and exclusive breastfeeding will be assessed at 60 ± 12 hours, 6, 10 and 14 weeks of age |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Healthy neonates born at (equal to or more than)35 weeks by vaginal delivery and not requiring early resuscitation. |
|
| ExclusionCriteria |
| Details |
Major congenital malformation(eg. omphalocele, gastroschisis, cleft lip, Cleft Palate, Upper Respiratory tract illness) which prohibits early SSC or breastfeeding.
Maternal complication in immediate post-partum period
Neonates requiring early resuscitation
Mentally ill mother
Mothers having any dermatologic morbidity over chest andtrunk which prohibit skin to skin contact.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Exclusive breastfeeding rate at 60±12 hours of age. |
Exclusive breastfeeding rate at 60±12 hours of age. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Breastfeeding behaviour at 60±12 hours of age and Exclusive breastfeeding rate at 6,10 and 14 weeks of age |
Breastfeeding behaviour at 60±12 hours of age and Exclusive breastfeeding rate at 6,10 and 14 weeks of age |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/09/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Skin to skin contact refers to placing of naked infant
prone on mother’s bare chest immediately after birth.
Randomized
control trial will be adopted to assess the effect of ninety minutes versus sixty minutes of early maternal newborn
skin to skin contact. Objectives of study are
to assess breastfeeding behaviour at 60±12
hours of age, exclusive breastfeeding rate at 60±12 hours of age, 6, 10 and 14
weeks. 198 maternal-newborn dyad will be included in the study by
the consecutive, Non- Probability Sampling Technique. Data will be collected by
the use of self-structured tool and standardized tools after taking permission
and written consent from the participants. After data collection, data will be
analysed by descriptive and inferential statistics
Key
words-
Breastfeeding Behaviour, Exclusive breastfeeding rate, Skin to skin contact |