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CTRI Number  CTRI/2025/10/095794 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Counselling and bedside assessment]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Impact of Virtual Newborn Adoption Program by Interns on Newborn health and Breastfeeding 
Scientific Title of Study   Effect of Virtual Newborn Adoption Program by Interns on Early Neonatal Outcomes and Breastfeeding Compared to Standard Postnatal Care – A Randomised Control Trial Study at a Rural Medical College (2025–2026) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nida Asif 
Designation  Assistant Professor 
Affiliation  Dr Chandramma Dayanada Sagar Institute of Medical Education and Research (CDSIMER) 
Address  Department of Pediatrics, CDSIMER, Devarakaggalahalli, Harohalli, Bengaluru south district

Bangalore Rural
KARNATAKA
562112
India 
Phone  8884582448  
Fax    
Email  nidaasif47@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nida Asif 
Designation  Assistant Professor 
Affiliation  Dr Chandramma Dayanada Sagar Institute of Medical Education and Research (CDSIMER) 
Address  Department of Pediatrics, CDSIMER, Devarakaggalahalli, Harohalli, Bengaluru south district


KARNATAKA
562112
India 
Phone  8884582448  
Fax    
Email  nidaasif47@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nida Asif 
Designation  Assistant Professor 
Affiliation  Dr Chandramma Dayanada Sagar Institute of Medical Education and Research (CDSIMER) 
Address  Department of Pediatrics, CDSIMER, Devarakaggalahalli, Harohalli, Bengaluru south district


KARNATAKA
562112
India 
Phone  8884582448  
Fax    
Email  nidaasif47@gmail.com  
 
Source of Monetary or Material Support  
Dr Chandramma Dayananda Sagar Institute of Medical Education and Research (CDSIMER), Harohalli 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nida Asif  Dept of Pediatrics  WARD 3, Fifth Floor, CDSIMER, Devarakaggalahalli, Harohalli
Bangalore Rural
KARNATAKA 
8884582448

nidaasif47@gmail.com 
Dr Nida Asif  Dr Chandramma Dayananda Sagar Institute of Medical Education and Research (CDSIMER)  OPD 7, Second Floor, Department of Pediatrics,Devarakaggalahalli, Harohalli, Bengaluru south district
Bangalore Rural
KARNATAKA 
8884582448

nidaasif47@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CDSIMER - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O927||Other and unspecified disorders oflactation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Routine postnatal care by hospital staff  
Intervention  Virtual Adoption by Interns  Counselling and Bedside Assessment of Postnatal mothers and Babies by medical interns with Daily bedside with until discharge and post discharge weekly virtual follow up via telephone  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  4.00 Day(s)
Gender  Both 
Details  1 Term or near-term newborns delivered in the hospital (GA greater than or equal to 34 weeks)
2 Birth weight greater than or equal to 2000 g
3 Mothers consenting to follow-up and data sharing and have access to mobile phone/internet for virtual follow-up
 
 
ExclusionCriteria 
Details  1 Neonates with major congenital anomalies
2 Neonates discharged to out-of-state regions with limited follow-up feasibility
3 Neonates with stormy Post natal course and transition – Neonates spending more than one day in NICU (Respiratory distress, Meconium Aspiration Syndrome, Sepsis, Seizures)
4 Multiple pregnancies
5 Maternal complications preventing breastfeeding initiation
6 Birth weight lesser than 2000 g
7 Preterm babies lesser than 34 weeks
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Neonatal weight gain  At discharge and 6 weeks follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Exclusive breastfeeding success rate  At discharge and 6 weeks follow up 
Breastfeeding assessment scores  At discharge and 6 weeks follow up 
latch scores   Day 1 ,Discharge day 
Maternal confidence in newborn care and satisfaction with healthcare services  At discharge and 6 weeks follow up 
incidence and time-to-detection of early neonatal complications (such as jaundice, feeding difficulties, and sepsis)  6 weeks follow up 
The feasibility and acceptability of intern-led virtual follow-up from the healthcare provider perspective  6 weeks follow up 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   29/10/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

 
1. Background and Rationale
1.1 Global and National Context
India accounts for approximately 20% of global neonatal deaths, with an estimated 0.6 million neonatal deaths annually (UNICEF, 2023). The National Family Health Survey-5 (2019-21) reported that while institutional deliveries have increased to 88.6%, structured post-discharge follow-up remains inadequate, particularly in resource-constrained settings.
1.2 Problem Statement
The critical transition period from hospital to home (first 6 weeks postpartum) represents a vulnerable window where 60% of neonatal complications manifest. Current standard care typically involves a single routine follow-up visit at 6 weeks, potentially missing early warning signs of feeding difficulties, weight loss, jaundice, or infection.
1.3 Innovation and Significance
Structured intern-led follow-up programs represent a scalable, cost-effective intervention that can bridge the gap between hospital discharge and routine paediatric care. By leveraging medical interns under supervision, hospitals can extend their care continuum without significant resource burden. The crucial role of interns is central to our proposed care model. Their dedicated twice-daily bedside visits and weekly virtual follow-ups enable intensive, personalized monitoring and systematic delivery of comprehensive counselling. This consistent, intern-led engagement significantly elevates the level of care beyond standard postnatal practices, directly contributing to improved adherence to optimal feeding and enhanced newborn well-being.
1.4 Literature Gap
While telemedicine and structured follow-up have shown promise in high-resource settings, evidence from Indian tertiary care hospitals using intern-led programs is limited. This study addresses this evidence gap
Expected Outcome & Application(s)
(the result that the researcher hopes to deliver after the successful completion of the project viz., approval/disapproval of hypothesis, contribution to knowledge, filling gaps in existing work, extending understanding of particular topics etc. and state how the outcome of the proposed study will be applied clinically)


The study is expected to demonstrate that an intern-led structured virtual follow-up program significantly improves exclusive breastfeeding rates, promotes better early weight gain, and enhances maternal confidence and satisfaction with postnatal care compared to standard practices. Additionally, it is anticipated that this approach will enable earlier detection of neonatal complications, thus reducing preventable morbidity during the vulnerable postnatal period. Successful results would support the hypothesis that integrating structured virtual follow-up bridges critical gaps in post-discharge care.
Clinically, the findings will provide evidence for implementing low-cost, scalable, and sustainable intern-led virtual follow-up models in tertiary and district hospitals across India. The program can serve as a template to strengthen breastfeeding promotion, early newborn monitoring, and maternal education within existing health systems, especially in resource-limited and rural settings. Ultimately, this will contribute to improved neonatal survival, reduced healthcare burden, and inform policy guidelines at state and national levels

 
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