| CTRI Number |
CTRI/2020/02/023308 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
11/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Poste delivery care on the abdomen at 28-32 weeks |
|
Scientific Title of Study
|
Feasibility of post delivery care on the abdomen of mothers in neonates born between 28-32 weeks. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Somashekhar Nimbalkar |
| Designation |
Professor of Pediatrics |
| Affiliation |
Pramukhswami Medical College |
| Address |
Ground Floor, Department of Pediatrics, HM Patel Academic Center, Gokalnagar, Karasmad, Anand, Gujarat
Anand
GUJARAT
388325
India |
| Phone |
09825087842 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Somashekhar Nimbalkar |
| Designation |
Professor of Pediatrics |
| Affiliation |
Pramukhswami Medical College |
| Address |
Ground Floor, Department of Pediatrics, HM Patel Academic Center, Gokalnagar, Karasmad, Anand, Gujarat
Anand
GUJARAT
388325
India |
| Phone |
09825087842 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna Herma |
| Designation |
Junior Resident |
| Affiliation |
Pramukhswami Medical College |
| Address |
Ground Floor, Department of Pediatrics, HM Patel Academic Center, Gokalnagar, Karasmad, Anand, Gujarat
Anand
GUJARAT
388325
India |
| Phone |
09825087842 |
| Fax |
|
| Email |
krishna.herma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Associate Dean (Research), Pramukhswami Medical College, Gokalnagar, Karamsad, Anand, Gujarat. |
|
|
Primary Sponsor
|
| Name |
Pramukhswami Medical College |
| Address |
Gokalnagar,
Karamsad, Anand, Gujarat |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Dipen Patel |
Labour Room, Shree Krishna Hospital |
Labour room, First Floor, Shree Krishna Hospital, Pramukhswami Medical College camous, Gokalnagar, Karamsad, Anand, Gujarat
Anand
GUJARAT |
09825087842
dipen_patel258@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Premature babies |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
All premature babies from 28-32 weeks |
|
| ExclusionCriteria |
| Details |
Congenital Malformations |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility of process |
One hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post partum depression |
three days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/02/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Skin
to skin and breast crawl have been shown to provide multiple benefits to the
mother and the new born [1-4]. Premature neonates are often not provided early
skin to skin because of the anticipation for need for resuscitation. The
Cochrane review on skin to skin after birth recommends that more studies need
to be conducted to find the effects of this process [5]. There are multiple
benefits of skin to skin care listed in the Cochrane review including thermal
benefits, breastfeeding benefits, emotional benefits, etc. There is a need to
explore the feasibility of this practice in preterm infants. It is also
necessary to find out what steps are needed to ensure that this is regularly
practiced. It is also pertinent to find out the responses of all the
stakeholders involved to get an idea of the comfort level to adapt to change |