CTRI Number |
CTRI/2014/05/004625 [Registered on: 26/05/2014] Trial Registered Retrospectively |
Last Modified On: |
23/11/2019 |
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
|
When to start kangaroo mother care (KMC - Skin to skin contact) in very low birth weight (VLBW) infants - Early or late? |
Scientific Title of Study
|
Randomized control trial comparing Early Vs Late Kangaroo Mother Care (KMC) in the kangaroo ward for stable very low birth weight infants for improving the growth outcomes at term corrected age. |
Secondary IDs if Any
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Srinivas Murki |
Address |
Fernandez Hospital,
Hyderguda,
Hyderabad
Hyderabad ANDHRA PRADESH 500029 India |
Phone |
9392470351 |
Fax |
|
Email |
srinivasmurki2001@gmail.com |
|
Details Contact Person Scientific Query
|
Name |
Dr Deepak Sharma |
Address |
Fernandez Hospital,
Hyderguda,
Hyderabad
Hyderabad ANDHRA PRADESH 500029 India |
Phone |
9849590876 |
Fax |
|
Email |
dr.deepak.rohtak@gmail.com |
|
Details Contact Person Public Query
|
Name |
Dr Deepak Sharma |
Address |
Fernandez Hospital,
Hyderguda,
Hyderabad
East Godavari ANDHRA PRADESH 500029 India |
Phone |
9849590876 |
Fax |
|
Email |
dr.deepak.rohtak@gmail.com |
|
Source of Monetary or Material Support
|
Fernandez Hospital, Hyderabad |
|
Primary Sponsor
|
Name |
Fernandez Hospital |
Address |
Fernandez Hospital, Hyderguda, Opp Old MLA quarters, Hyderabad |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Srinivas Murki |
Neonatal Intensive Care Unit - KMC ward |
Second floor, Fernandez Hospital,Hyderguda, Hyderabad Hyderabad |
9392470351
srinivasmurki2001@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committe, Fernandez Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Neonates with birth weight less than 1100 gm |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
Early Kangaroo Mother Care (KMC) |
early Kangaroo mother care once the infant reaches a weight of 1150grams and baby will be followed till post menstrual age of 40 weeks of gestation.During this period, mothers will be encouraged to do KMC for at least 6 hours. |
Comparator Agent |
Late Kangaroo mother care |
Late Kangaroo mother care once the infant reaches a weight of 1250grams.baby will be followed till post menstrual age of 40 weeks of gestation.During this period, mothers will be encouraged to do KMC for at least 6 hours |
|
Inclusion Criteria
|
Age From |
1.00 Day(s) |
Age To |
3.00 Month(s) |
Gender |
Both |
Details |
Infant fulfilling the following criteria
•Birth weight less than 1100 grams
•Singleton
•Tolerating spoon or tube feeds of 150 mL/kg/day and not on intravenous fluids
•Breathing room air
•Hemodynamically stable
|
|
ExclusionCriteria |
Details |
Infants born with major malformations |
|
Method of Generating Random Sequence
|
Stratified randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Weight, Length and Head Circumference |
At 40 weeks of gestation |
|
Secondary Outcome
|
Outcome |
TimePoints |
Breastfeeding rates |
at discharge and at 40 weeks |
Cost differences between the two groups |
At discharge |
In hospital weight gain (gm/kg/day), length (cm/week) and OFC (cm/week) |
till discharge |
Readmission to NICU (level III or intermediate care) |
Till 40 weeks of gestation |
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
13/11/2013 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Eur J Pediatr Aug 2016 |
Brief Summary
Modification(s)
|
Kangaroo mother care (KMC) reduces neonatal mortality, neonatal sepsis and improves growth outcome in preterm infants. In this study, we compared the efficacy of Bbaby care in kangaroo ward (KWC)^ with Bbaby care in intermediate intensive care (IIC)^ in stable preterm infants (birth weight <1100 g) for improving the growth velocity till term corrected age. One hundred and forty-one infants were randomized to KWC (n = 71) or IIC (n = 70) once the infant reached a weight of 1150 g. Infants in the KWC group were shifted to the KWC immediately after randomization and those in the IIC group were given care in the IIC till they attained a weight of 1250 g and then shifted to the KWC. The average weight gains as well as weight, length, and head circumference at term corrected age were comparable in both the groups. There was significant reduction in IIC stay post randomization and increase in weight gain before discharge in the KWC group. There was a significant increase in incidence of apnea in the IIC group. |