| CTRI Number |
CTRI/2024/09/074097 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Kangaroo
Mother Care on Preterm
babies |
|
Scientific Title of Study
|
Effectiveness of Kangaroo
Mother Care on Preterm
babies in Tertiary care
hospital: A Randomized
controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/RMCH/99/2024/APR |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr CHINNADURAI M |
| Designation |
Junior Resident |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,BAREILLY |
| Address |
Room No.3008,Department of Paediatrics, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
7397246211 |
| Fax |
|
| Email |
mchinnadurai096@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr ROSHAN LAL SHARMA |
| Designation |
PROFESSOR |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,BAREILLY |
| Address |
Room No.3004,Department of Paediatrics, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9418150377 |
| Fax |
|
| Email |
drroshan16@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr CHINNADURAI M |
| Designation |
Junior Resident |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,BAREILLY |
| Address |
Room No.3008,Department of Paediatrics, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
7397246211 |
| Fax |
|
| Email |
mchinnadurai096@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly-243006, Uttar pradesh, India. |
|
|
Primary Sponsor
|
| Name |
Dr CHINNADURAI M |
| Address |
Department of Paediatrics, Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly-243006, Uttar Pradesh, India. |
| 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 |
| DR CHINNADURAI M |
Rohilkhand Medical College and Hospital |
Room No.3004, Department of Paediatrics, 2 nd floor, Pilibhit Bypass Road, Pawan Vihar, Bareilly, Uttar pradesh-243006 Bareilly UTTAR PRADESH |
7397246211
mchinnadurai096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,RMCH,BAREILLY,U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group provided with Kangaroo Mother Care (Interventional group) |
KMC group -Kangaroo mother care with normal routine NICU care.
KMC in KMC group neonate provided for maximum possible duration in a day till mother will be comfortable [minimum 4 hours per day].
Drug Not applicable,
No drug therapy.
|
| Comparator Agent |
Group provided with Routine care (Control group) |
Routine new born care.
Drug Not applicable,
No drug therapy.
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
All Hemodynamically stable preterm neonates admitted in NICU and Postnatal ward after delivery at Rohilkhand Medical College and Hospital |
|
| ExclusionCriteria |
| Details |
1.Neonates with major congenital malformation.
2.Perinatal Asphyxia [HIE II/HIE III].
3.Intraventricular Hemorrhage greater than 2 grade.
4.Neonates requiring any surgical intervention.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Average weight gain
2.Frequency of feed intolerance in terms of feed regurgitation and abdominal distention
3.Presence of necrotizing enterocolitis
4.Duration of Hospital stay
5.Vital parameters (Heart Rate, Respiratory Rate, SpO2)
|
At the time of discharge, Patients anthropometric indices like weight, Length and head circumference will be recorded. Then
patients will be followed up in paediatric OPD at 6 weeks, 10 weeks and at 14 weeks of age and at 6 months of age. The weight, length and head circumference will be recorded with each follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of Hospital stay |
At the time of discharge, Patients anthropometric indices like weight, Length & head circumference will be recorded. Then patients will be followed up in paediatric OPD at 6 weeks, 10 weeks & at 14 weeks of age & at 6 months of age. The weight, length & head circumference will be recorded with each follow up. |
|
|
Target Sample Size
|
Total Sample Size="88" Sample Size from India="88"
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)
|
15/10/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After taking clearance from Institutional Ethics Committee,
Rohilkhand Medical College and Hospital, Bareilly, the study will be
conducted. ï‚· Written informed consent will be taken from parents/guardians of all the
patients participating in the study in a language they can understand.
Anonymity will be proposed as optional and confidentiality will be
maintained. ï‚· All babies fulfilling inclusion criteria randomized in two groups: Group 1: KMC group -Kangaroo mother care with normal routine NICU
care Group 2: Control group –Routine new born care For randomization, we use computer generated random numbers. Blinding: The sealed envelope will be opened by the staff on duty under
the supervision of study doctor. The interventions which will be written
on the slip will be carried out by the resident doctors and staff on duty
not involved in the study. INTERVENTION-Residents doctors and staff involved in KMC of
neonates trained for Kangaroo mother care by showing live demonstration of KMC by primary investigators and showing a video
produced by World Health Organization in collaboration with AIIMS,
New Delhi. Randomly allocated intervention group neonates with KMC
during KMC position by trained staff and resident doctors according to
the treatment orders and protocols specified in AIIMS NICU protocol.
KMC in KMC group neonate provided for maximum possible duration
in a day till mother will be comfortable [minimum 4 hours per day]. ï‚· A comfortable environment will be provided for mothers by wearing
hospital clothes after washing their hands, keeping the opening in front,
and then lying on the bed and head elevated to a 45° angle to provide a
comfortable reclining position. In order to emphasize skin-to-skin
contact, the newborn was then placed on the mother’s bare chest while
only wearing a diaper, socks, cap, and mittens. In order to maintain the
newborn’s open airway and promote mother-child eye contact, a soft
blanket was placed around the mother and child. To help with KMC, the
mother’s hands were placed over the blankets and gently pressed against
the neonate’s back to stabilize them. ï‚· Determine a time that’s suitable for the mother and the baby when the child is ready
for KMC. The early sessions are crucial and require for a lot of interactions. Explain her how to adhere to the KMC process patiently, gently, and with compassion. Invite
her to bring her husband, mother-in-law, or any other family member. It contributes
to the family’s positive mental state and guarantees the mother’s support. Short: 4 hours a day. Extended: five to eight hours per day. Length: nine to twelve hours every day. Continuous: More than twelve hours per day recorded for at least two days
consecutively or more before being discharged. ï‚· KMC is linked to a lower incidence of serious illnesses in neonates, such as
pneumonia. KMC has been found to be more effective than incubator care for stable
newborns in the majority of studies. This is because KMC encourages greater
maternal and family involvement in care, provides adequate thermal care, reduces
nosocomial infections, improves exclusive breastfeeding and weight gain, and is
less expensive than incubator care. The baby’s five senses are fully satisfied by
KMC. The baby listens to her mother voice and has skin-to-skin contact (touch) to
sense the warmth of her mother, listens to her voice and heartbeat (hearing), sucks
breast milk (taste) has eye contact with her (vision) and smells her odor (olfaction) ï‚· Following that, a pulse oximetry probe will be attached to
the neonate’s right wrist prior to feeding in order to measure vital signs like heart rate and oxygen saturation. For an entire one minute, the
respiratory rate was recorded.
 Finally after 30 minutes of feed administration and KMC neonates’
physiological parameters and feeding intolerance parameters were
assessed including any feed regurgitation and abdominal distension.
KMC was continued for maximum possible duration. Feed intolerance
and NEC grading was defined based on AIIMS NICU protocol. |