| CTRI Number |
CTRI/2024/11/077455 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [kangaroo mother care] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Kangaroo mother care in non invasive ventilated infants |
|
Scientific Title of Study
|
Effect of Kangaroo Mother Care In Low birth weight infants with non invasive ventilation Randomised control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
lakshmi ravali |
| Designation |
junior resident |
| Affiliation |
mgm medical college and hospital |
| Address |
room no 360 , third floor , department of pediatrics , mgm medical college , aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8073021550 |
| Fax |
|
| Email |
drlakshmiravali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sunil gavhane |
| Designation |
professor |
| Affiliation |
mgm medical college and hospital |
| Address |
room no. 5 ,2nd floor , paediatrics neo care hospital , sutgirni chowk , gharkeda , aurangabad
room no 1 . 3 rd floor , department of paediatrics, mgm hospital , aurangabad
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9158675555 |
| Fax |
|
| Email |
drsunildg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sunil gavhane |
| Designation |
professor |
| Affiliation |
mgm medical college and hospital |
| Address |
room no 5 , 2nd floor , department of paediatrics ,neo care hospital , sutgirni chowk , gharkeda , aurangabad
room. no 1 , 3rd floor , department of paediatrics , mgm medical college , aurangabad
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9158675555 |
| Fax |
|
| Email |
drsunildg@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM MEDICAL COLLEGE, AURANGABAD ,MAHARASTRA, 431001 INDIA |
|
|
Primary Sponsor
|
| Name |
Ravaliramula |
| Address |
room no 360, third floor , department of paediatrics , N6 CIDCO , MGM Medical college |
| Type of Sponsor |
Other [principal investigator -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 |
| dr lakshmiravali |
MGM medical college |
room no. 360, department of pediatrics, first floor ,MGM Hospital, N 6 , CIDCO,
Aurangabad
MAHARASHTRA |
8073021550
drlakshmiravali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGMECHRS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P009||Newborn affected by unspecified maternal condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparing the non invasive ventilated infants with kangaroo mother care and with out kangaroo mother care |
non invasive ventilated infants are randomized give kangaroo mother care and compare weight gain and duration of hospital stay with infants not receiving kangaroo mother care |
| Intervention |
kangaroo mother care |
skin to skin contact between mother and preterm / low birth weight infants total duration includes from admission to discharge of patient from nicu |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
low birth weight infants less than 2500grams
preterm
|
|
| ExclusionCriteria |
| Details |
weight more than 2500gms
infants on invasive ventilation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
success and failure rate of intervention done .sucess is defined as patient not requiring invasive ventilation , weight gain and less hospital stay time line is considered till the discharge of patient from nicu
failure is defined as patient requiring invasive ventilation , weight loss , long duration of hospital stay |
monitoring the specified outcomes of the patient daily from admission till discharge from nicu |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| success & failure rate of intervention done .sucess is defined as patient require less days to reach full feeds, failure is defined as patient requiring more days |
success & failure rate of intervention done . time line considered till the discharge of patient from nicu , outcomes will be monitored last day of the dischage . |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
10/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/12/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
aim: effect of kangaroo mother care in low birth weight infants in non invasive ventilation
primary objective : to study the effect of kmc , duration of respiratory support in lbw infants requiring non invasive ventilation secondary objective : to compare duration of hospital stay , mortality , neonatal sepsis , hyperthermia, necrotizing enterocolitis , rop of infants with kmc and without kmc |