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CTRI Number  CTRI/2025/12/099989 [Registered on: 31/12/2025] Trial Registered Prospectively
Last Modified On: 29/12/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Teaching Mothers About Care of Premature Babies in the NICU 
Scientific Title of Study   Impact of educational training on maternal bonding, self-efficacy, and self-confidence in mothers of preterm neonates admitted in NICU. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Gayathri Renganathan 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Pediatrics, Ground Floor, Kasturba Medical College Attavar, Mangaluru, Karnataka – 575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9632866222  
Fax    
Email  gayathri.renganathan@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayathri Renganathan 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Pediatrics, 203, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka 575001, India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9632866222  
Fax    
Email  gayathri.renganathan@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Renganathan 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Pediatrics, 203, Light House Hill Rd, Hampankatta, Mangaluru, Karnataka 575001, India

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9632866222  
Fax    
Email  gayathri.renganathan@manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
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 
Dr Gayathri Renganathan  Government Lady Goschen Hospital  Department of Neonatology (NICU), Ground Floor, Maidan Road, Bhavathi, Hampankatta, Mangaluru, Karnataka – 575001
Dakshina Kannada
KARNATAKA 		 96328 66222

gayathri.renganathan@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O908||Other complications of the puerperium, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational video-based training program on maternal and newborn care for mothers of preterm infants  Structured educational video module on maternal and newborn care, consisting of a 40 minute prerecorded video covering topics such as care of preterm infants, breastfeeding, infection prevention, kangaroo mother care, and maternal confidence in caregiving. The video will be administered to mothers in the intervention arm during their NICU stay, using a mobile device or any screen provided by the investigator, and will be shown in one or more sessions based on the mothers convenience and clinical condition. The intervention will be delivered once during the hospital stay, under the supervision of the investigator or research staff, in addition to routine care. 
Comparator Agent  Usual postnatal care without video training  Mothers in the control arm will receive standard postpartum counseling and routine care as per existing hospital NICU protocols, provided by nursing staff and treating doctors. This includes verbal counseling on breastfeeding, newborn care, and discharge advice, delivered as part of routine clinical practice. No structured educational video module or additional educational material will be provided to participants in the control arm. The content, duration, and frequency of counseling will be as per routine hospital practice 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1) Mothers of preterm neonates that were admitted in the NICU for routine preterm care
2) Mothers of preterm babies who did not require advanced interventions like mechanical ventilation, CPAP, Inotropes, etc.
3) Mothers of pre-term babies who did not require advanced resuscitation/intervention during childbirth
4) Mothers who did not have a diagnosed psychiatric illness/chronic illness
5) Mothers who consented to be in the study 
 
ExclusionCriteria 
Details  1) Mothers who are unwilling to participate
2) Mothers of neonates with complex conditions like congenital heart diseases, congenital anomalies, genetic syndromes, etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in test scores before and seven days after intervention which is measured using validated tools (Mother-to-Infant Bonding Scale [MBS], Perceived Maternal Parenting Self-Efficacy [PMP-SE] scale, and Parenting Sense of Competence Scale [PSCS]).  within 72 hours of postpartum and seven days post-intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in post-intervention scores between intervention and control groups at 7 days post-intervention.  Seven days post-intervention 
Proportion of mothers in each arm achieving a clinically meaningful increase in Perceived Maternal Parenting Self-Efficacy score, defined as an increase of greater than or equal to 0.5 times the baseline standard deviation  Seven days post-intervention 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/01/2027 
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="4"
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   This study is randomized, open blind, and parallel which compares the test scores of mothers who have preterm babies admitted in the NICU. Standardized tests will be given 72 hours postpartum and again 7 days post-intervention to both groups. The primary outcome is the change in test scores before and seven days after intervention which is measured using validated tools (Mother-to-Infant Bonding Scale [MBS], Perceived Maternal Parenting Self-Efficacy [PMP-SE] scale, and Parenting Sense of Competence Scale [PSCS]). The secondary outcome will be the difference in post-interventional scores between interventional and control groups at 7 days post-intervention. Another secondary outcome will be the proportion of mothers in each arm achieving a clinically meaningful increase in the Perceived Maternal Self-Efficacy scores, defined as an increase of greater than or equal to 0.5 times the baseline standard deviation. 
 
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