FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/04/052060 [Registered on: 27/04/2023] Trial Registered Prospectively
Last Modified On: 26/04/2023
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   Impact of continuous kangaroo mother care initiated immediately after birth(iKMC)  
Scientific Title of Study   Impact of continuous kangaroo mother care initiated immediately after birth(iKMC) on newborns with birth weight between 1 to 1.5kg 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Maanasa G 
Designation  2ND YR JUNIOR RESIDENT  
Affiliation  KLES.DR.P.K.HOSPITAL AND MRC 
Address  DEPARTMENT OF PEDIATRICS, GROUND FLOOR,KLES DR.P.K.HOSPITAL AND MRC,NEHRU NAGAR, BELAGAVI
DEPARTMENT OF PEDIATRICS, GROUND FLOOR,KLES DR.P.K.HOSPITAL AND MRC,NEHRU NAGAR, BELAGAVI
Belgaum
KARNATAKA
590010
India 
Phone  9176416517  
Fax    
Email  maanasaguna96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr N S Mahantashetti 
Designation  Principal of JNMC  
Affiliation  Dr.Prabhakar Kore Hospital and medical research centre, Nehru nagar  
Address  JNMC, KLES Dr.Prabhakar Kore Hospital and medical research centre, Nehru nagar
Dr.Prabhakar Kore Hospital and medical research centre, Nehru nagar , Belagavi-590010, Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  7019859458  
Fax    
Email  ranjdevi.maanu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Maanasa G 
Designation  2ND YR JUNIOR RESIDENT 
Affiliation  Dr.Prabhakar Kore Hospital and medical research centre, Nehru nagar  
Address  DEPARTMENT OF PEDIATRICS, GROUND FLOOR,KLES DR.P.K.HOSPITAL AND MRC,NEHRU NAGAR, BELAGAVI
DEPARTMENT OF PEDIATRICS, GROUND FLOOR,KLES DR.P.K.HOSPITAL AND MRC,NEHRU NAGAR, BELAGAVI
Belgaum
KARNATAKA
590010
India 
Phone  9176416517  
Fax    
Email  maanasaguna96@gmail.com  
 
Source of Monetary or Material Support  
Dr.Prabhakar Kore Hospital and medical research centre, Nehru nagar , Belagavi-590010, Karnataka 
 
Primary Sponsor  
Name  Maanasa G 
Address  Room no:507, New PG ladies hostel, KLES Dr.Prabhakar Kore Hospital , Nehru nagar, Belagavi-590010, Karnataka 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Maanasa G  KLES, Dr. Prabhakar Kore hospital and medical research centre  KLES, Dr. Prabhakar Kore hospital and medical research centre, Nehru nagar, Belegavi-590010, Karnataka
Belgaum
KARNATAKA 
9176416517

maanasaguna96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMIITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P071||Other low birth weight newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional kangaroo mother care after 72 hrs of life  Kangaroo mother care provided before 72 hours of life versus after 72 hours of life 
Intervention  Immediate kangaroo mother care before 72 hours of life   Kangaroo mother care provided before 72 hrs of life versus after 72 hours of life 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  All infants born alive in the participating hospitals with a birth weight from 1.0 to less than 1.5 kg, regardless of their gestational age, are eligible for participation in this trial with their mothers. It should be a singleton pregnancy. The mother–infant pair is eligible even if the mother experiences some complications during labour and delivery that are expected to be resolved within 3 days. 
 
ExclusionCriteria 
Details  1. The mother is younger than 15 years of age

2. The mother is unable or unwilling to provide consent

3. The mother is unlikely to be able to provide KMC initiation within the first 3 days after birth (eg: eclampsia or shock or has undergone major surgery)

4. Baby is unable to breathe spontaneously within 1 hour of birth

5. Baby on ventilatory support

6. Multiple gestation

7. Baby has a congenital malformation that interferes with the intervention or the intervention interferes with the care for the congenital malformation


8. If for any other reason the mother infant pair cannot be enrolled within 2 hours of birth of infant.

9. If mother not able to provide immediate KMC or willing relative.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Impact of immediate KMC vs Neonatal Intensive Care using warmer in preterm infants weighing (1-1.5kg) on early neonatal mortality, in a tertiary care hospital  Jan 2023-Jan 2024 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the effect of the intervention on:
1.Time taken for physiological stabilization
2.Hypothermia
3.Time taken to reach full breast feeding
4.Hypoglycemia
5.Clinically suspected sepsis
6. Duration of hospital stay
7.Weight gain of infants
 
Jan 2023-Jan 2024 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/05/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Mother infant pair who meets the eligibility criteria will be enrolled into the study after obtaining written informed consent from pregnant mothers in the labour room. Consenting mothers are asked to identify one or two adult relatives or friends of their choice who could act as their surrogates for providing SSC when and if they are not able to do so. Surrogates have their role in the study explained to them if the mother–infant pair is randomly assigned to the intervention group. 

If the infant is allocated to the intervention group, the nurse who attends all deliveries of potential babies helps the mother (or the surrogate in case the mother is indisposed) to initiate KMC as soon as possible after randomization. Monitoring of oxygen saturation and heart rate is carried out by using a pulse oximeter. The nurse also helps to transfer the mother (or surrogate) and the baby to the NICU in SSC. The researcher continues to support the mother or surrogate to provide continuous KMC after the baby is admitted to the NICU. 

The infant is kept in SSC (atleast 12hrs per day) as much as possible, preferably with the mother but with a surrogate for the time when the mother cannot provide the intervention. In KMC, the infant is put naked on the mother’s chest. The infant has a cap, diaper, and socks and is secured firmly to the chest with a binder that ensures a patent airway and a shirt that provides containment in the fetal position. All routine care is provided in SSC. Any interruptions in SSC are documented to determine the duration for which the intervention was provided per day. The nurse also supports the mother in early expression of milk and to help the baby suckle at the breast. 

If the infant is allocated to the control group, routine care is provided by hospital staff. The infant is transferred to the NICU in a radiant warmer as soon as possible. When discharged from the delivery room or operation theatre, the mother is transferred to the postnatal ward and the infant remains in the NICU in accordance with current guidelines. When the infant is ready to be fed, the mother provides expressed breast milk. After the stabilisation of the infant , the mother provides KMC as per the current WHO guidelines

In both the groups, infant in the NICU is monitored, and information regarding temperature, heart rate, respiratory rate anthropometry and oxygen saturation is recorded every 6h. Blood sugar similarly is monitored every 6h during the first 24h after birth and thereafter as and when required. In the KMC ward, infants are evaluated every 12 h up to hospital discharge. Measures will be taken to avoid contamination and special care would be taken to separate them. All other nursing care will be same for both the groups.

 
Close