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临床试验/CTRI/2025/10/095794
CTRI/2025/10/095794尚未招募不适用

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)

未提供2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年10月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
110
试验地点
2
主要终点
Neonatal weight gain

研究概览

简要总结

  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

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 4.00 Day(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Neonatal weight gain

时间窗: At discharge and 6 weeks follow up

次要结局

  • 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)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Nida Asif

Dr Chandramma Dayanada Sagar Institute of Medical Education and Research (CDSIMER)

研究点 (2)

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