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临床试验/CTRI/2025/08/092356
CTRI/2025/08/092356尚未招募不适用

Effect of structured quality improvement interventions on early initiation of breastfeeding among newborns at a tertiary health care hospital: A Quasi-experimental Study

Maharaja Agarsen Medical College1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2025年8月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
85
试验地点
1
主要终点
Proportion of newborns recieving Early initiation of Breastfeeding (Within First hour of life)

研究概览

简要总结

The proposed study titled “Effect of Structured Quality Improvement Interventions on Early Initiation of Breastfeeding Among Newborns at a Tertiary Health Care Hospital: A Quasi-experimental Study” aims to enhance the rate of breastfeeding initiation within one hour of birth (EIBF), a WHO-recommended practice proven to reduce neonatal morbidity and mortality. Despite known benefits, EIBF rates remain low, particularly in tertiary settings. This study will be conducted in the Departments of Pediatrics and Obstetrics & Gynaecology at Maharaja Agrasen Medical College, Agroha, and will use the Plan-Do-Study-Act (PDSA) cycle framework to implement structured quality improvement (QI) interventions. Healthcare providers—doctors, residents, and nurses—will be sensitized through educational sessions, posters, checklists, and digital reminders. The intervention will be conducted in two phases, assessing baseline data followed by implementation and post-intervention analysis to track improvements. Exclusions include neonates with congenital feeding issues, NICU admissions, or severe maternal complications. Sample size will include all eligible 85 newborns during the study window, estimated using OpenEpi. The primary outcome will be the improvement in EIBF rates, and secondary outcomes include identifying barriers like staff training gaps, interdepartmental miscommunication, and post-operative delays. Data will be collected in structured proformas and analyzed using standard statistical tools. Ethical clearance will be obtained, and written informed consent will be taken. This study aims to offer a scalable, sustainable model for enhancing early breastfeeding, with the potential to impact neonatal care policies and protocols in similar healthcare settings across low- and middle-income countries.

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
0.00 Day(s) 至 2.00 Day(s)(—)
性别
All

入选标准

  • All live-inborn neonates whose parents give consent for participation in the study.

排除标准

  • Neonates with any congenital anomalies affecting feeding (e.g., cleft lip/palate, tracheoesophageal fistula).
  • New-born requiring NICU (Neonatal Intensive Care Unit) admission or intensive monitoring post-delivery.
  • When breast feeding is not indicated (e.g., Galactosemia, active herpes infection).
  • Severe obstetric complications leading to ICU admission of mother (e.g., postpartum hemorrhage needing surgery or ventilation).
  • Deliveries conducted outside the hospital (out-born).

结局指标

主要结局

Proportion of newborns recieving Early initiation of Breastfeeding (Within First hour of life)

时间窗: First hour after Birth

次要结局

未报告次要终点

研究者

发起方
Maharaja Agarsen Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Deepanshu Sharma

Maharaja Agrasen Medical College Agroha

研究点 (1)

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