| 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
|
|
|
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
|
|
|
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. |