| CTRI Number |
CTRI/2021/10/037264 [Registered on: 12/10/2021] Trial Registered Prospectively |
| Last Modified On: |
11/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Kangaroo mother care] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of effect of early kangaroo mother care on babies with birth weight less than 1500grams |
|
Scientific Title of Study
|
“Impact of early initiation of Kangaroo Mother Care on Moderately Sick Neonates Weighing ≤ 1500 Grams: A Randomized Controlled Trial in a tertiary care hospital.†|
| Trial Acronym |
eKMC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanju Sidaraddi |
| Designation |
Neonatology Resident |
| Affiliation |
KEM hospital research centre |
| Address |
Department of Neonatology
KEM Hospital
Sardar Moodaliar Road Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8105980805 |
| Fax |
|
| Email |
reddysanju0208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanju Sidaraddi |
| Designation |
Neonatology Resident |
| Affiliation |
KEM hospital research centre |
| Address |
Department of Neonatology
KEM Hospital
Sardar Moodaliar Road Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8105980805 |
| Fax |
|
| Email |
reddysanju0208@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Kadam |
| Designation |
Consultant Neonatologist |
| Affiliation |
KEM hospital Pune |
| Address |
Department of Neonatology
KEM Hospital
Sardar Moodaliar Road Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9850609628 |
| Fax |
|
| Email |
drsandeepkadam@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 SANDEEP KADAM |
KEM HOSPITAL PUNE |
489 SARDAR MUDALIAR ROAD RASTA PETH PUNE
Pune
MAHARASHTRA |
9850609628
drsandeepkadam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KEM HOSPITAL RESEARCH CENTRE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Premature very low birth weight infant |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
kangaroo mother care |
standard of care of arm who start receiving KMC after they attain full feeds and hemodynamically stable |
| Intervention |
Kangaroo mother care |
The preterm infant, wearing only a diaper, will be put against the mother’s bare breast, in the upright position, prone posture. Front-opening regular clothing will be used for mothers, caps, and socks will be used for babies. for moderately sick newborns Kangaroo mother care will be started within first 7 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Month(s) |
| Gender |
Both |
| Details |
Preterm babies weighing ≤ 1500 grams
Age: within 7 days of life
Mother or any other caregiver available and willing to provide KMC
Babies with stable cardio-respiratory parameters i.e. requirement of one inotrope, ≤2 apnea episodes in 24 hours, babies on respiratory support (MAP < 8 cms and FIO2< 60%) both invasive and non-invasive ventilation.
|
|
| ExclusionCriteria |
| Details |
1. Neonates with major congenital anomalies and syndromic babies.
2. Neonates on high-frequency ventilation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of early KMC in babies weighing ≤ 1500 grams on hospital stay compared with standard care. |
AT 40 WEEKS OF GESTATIONAL AGE
AT 18 MONTHS OF AGE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the incidence of sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, intraventricular hemorrhage, apnoea, and feed intolerance.
2. To study the growth at 40 weeks corrected age in both the groups for extra-uterine growth retardation (EUGR).
3. To study neurodevelopmental outcome at 18 months of age
4. To study the mortality rates |
at the time of discharge and at 18 months of age.
|
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
25/10/2021 |
| 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
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Kangaroo mother care (KMC) is a very effective intervention for improving outcomes among preterm low birth weight neonates. KMC compared to standard of care has reduced neonatal mortality in Low Birth Weight (LBW) neonates by 36%. Early Skin to Skin Contact (SSC) among term neonates has shown beneficial effects on breastfeeding one to four months post-birth, blood glucose, infant crying, and infant temperature stability. However, studies regarding KMC given to very preterm neonates especially neonates weighing ≤1500 grams, initiated early during NICU stay are limited. This period is very fragile especially when the neonates are on respiratory support and are prone to hemodynamic instability and as result vulnerable to higher morbidities and mortality. We aim to conduct a randomized control trial to find out the outcome in moderately sick neonates weighing ≤1500 grams with early initiation of KMC vs. those with no early KMC (standard care). |