| 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 |
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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 |
|
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CDSIMER - Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O927||Other and unspecified disorders oflactation, |
|
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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
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Neonatal weight gain |
At discharge and 6 weeks follow up |
|
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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 |
|
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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
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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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