| CTRI Number |
CTRI/2014/02/004437 [Registered on: 27/02/2014] Trial Registered Prospectively |
| Last Modified On: |
27/02/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Influence of immediate skin to skin contact on physiological parameters of the newborn |
|
Scientific Title of Study
|
Influence of immediate skin to skin contact on physiological parameters of the newborn |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Somashekhar Nimbalkar |
| Designation |
Professor of Pediatrics |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department of Pediatrics,
Pramukhswami Medical College,
Karamsad-Anand-Gujarat.
Pin-388325
Anand
GUJARAT
388325
India |
| Phone |
9825087842 |
| Fax |
02692223466 |
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhaval Patel |
| Designation |
Research Assistant |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department of Pediatrics,
Pramukhswami Medical College,
Karamsad-Anand-Gujarat.
Pin-388325
Anand
GUJARAT
388325
India |
| Phone |
7874384146 |
| Fax |
02692223466 |
| Email |
dhavalpatel1426@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Somashekhar Nimbalkar |
| Designation |
Professor of Pediatrics |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department of Pediatrics,
Pramukhswami Medical College,
Karamsad-Anand-Gujarat.
Pin-388325
Anand
GUJARAT
388325
India |
| Phone |
9825087842 |
| Fax |
02692223466 |
| Email |
somu_somu@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Charutar Arogya Mandal |
| Address |
Gokalnagar, Karamsad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Somashekhar Nimbalkar |
Pramukhswami Medical College Labour Room |
Shree Krishna Hospital
Gokalnagar,Anand-388325
Anand
GUJARAT |
9825087842
somu_somu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, HM Center for Medical Care and Education |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Newborns |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal care |
Infants will be kept in warmer and not receive skin to skin care. Heart rate, saturation and temperature will be check ed in this group too. |
| Intervention |
Skin to Skin care |
In the randomized trial we shall keep the intervention group in skin to skin care for two hours after birth and monitor saturation of the two groups. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
Neonates more than 34 weeks in gestation as per available records. |
|
| ExclusionCriteria |
| Details |
newborn not having respiratory distress or congenital malformation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to reach oxygen saturation of 90% or more. |
Time to reach oxygen saturation of 90% or more. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate, temperature and respiratory rate |
every few minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/03/2014 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
·
The
project is aimed to provide relevant statistics comparing the vitals of new-borns subjected to immediate skin-to-skin contact to that of new-borns received under servo-control warmer. The statistical data so obtained would help to understand the extent of influence that skin-to-skin contact has on physiological parameters of the new-born and whether this method employed immediately after birth impacts the physiological parameters significantly enough as compared to the conventional method of receiving the baby after birth. This information, in turn would guide doctors as to how effective is the immediate skin-to-skin contact method employed after birth of the baby as far as maintaining the vital physiological parameters are concerned and further modify appropriately, the mode of managing a new-born immediately after birth.
|