Piloting and refinement of an in-facility supportive care package for optimal feeding and preventive-promotive care of low birthweight and preterm infants admitted to level-2 neonatal intensive care units
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- 1. Mean timing baby first fed mother breast milk post-birth
研究概览
简要总结
Numerous curricula and guidelines encompass elements of crucial principles related to lactation support, Kangaroo Mother Care (KMC), and Water, Sanitation, and Hygiene (WASH). However, a significant gap exists in the form of a comprehensive package that integrates all essential components of preventive-promotive care. This care is intended to be delivered by health providers to both newborns and mothers, ensuring optimal health and growth outcomes for small and vulnerable infants. As part of a global initiative, PATH, in collaboration with USAID, is actively developing a package focused on Specialized Lactation Support and Newborn Nutrition for Small and Sick Newborns. This effort includes the creation of a training curriculum, guide, Standard Operating Procedures (SOPs), and job aids.
The package is designed to build upon existing curricula, filling gaps in newborn feeding and lactation management. Additionally, elements of Kangaroo Mother Care (KMC) and Water, Sanitation, and Hygiene (WASH) are being incorporated to form the comprehensive "in-facility feeding support plus package." A co-design workshop, engaging key stakeholders such as obstetricians, pediatricians, and nursing teams, was conducted in partnership with Ariadne Labs and PATH. The workshop aimed to understand existing guidelines, care workflows, identify gaps, and determine needs. The insights from this workshop are being integrated into the development of the "in-facility feeding support plus" package. The primary objective of this study is to pilot the developed "in-facility feeding support plus" package, utilizing skilled study nurses. The rigorous evaluation will focus on assessing the impact of the ideal delivery of the package on newborn feeding, KMC and WASH practices, infant growth, and maternal self-efficacy. These outcomes will be compared against a baseline.
Additionally, the study will evaluate the acceptability and feasibility of the package itself. The data collected will be systematically analyzed and shared with the Ariadne Labs team to refine the package for deployment in an implementation setting. The goal is to create a globally harmonized package with universal elements for use across countries and sites, incorporating locally contextualized and adapted elements applicable to Uttar Pradesh (UP) and India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 27.00 Day(s)（—）
- 性别
- All
入选标准
- •LBW (less than 2.5 kg) or preterm (less than 37 weeks) infants admitted in the NICU of the study facility.
- •In-born infants admitted to the NICU within 24 hours of birth
- •Mother and infant alive during screening
- •Mother consents for herself and infant
- •Women (mothers) who are 18+ years of age
- •All clinical study team members to be included with no exclusions.
排除标准
- •Out-born infants referred to study facility NICU.
- •Congenital anomalies or acquired conditions that interfere with feeding or placement of nasogastric or orogastric (NG or OG) tube [e.g., cleft lip or palate, toxoplasmosis,other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital cardiac defect, neural tube defect, gastrointestinal (GI) tract anomalies, hydrocephalus, NEC]
- •Severe birth asphyxia
- •Unknown date of birth and or unknown gestational age.
结局指标
主要结局
1. Mean timing baby first fed mother breast milk post-birth
时间窗: Daily till the discharge of newborn or 14 days after admission whichever is earlier
2. Mean time to mother first breast stimulation via first breast milk expression or baby first put to breast
时间窗: Daily till the discharge of newborn or 14 days after admission whichever is earlier
3. Mean number of mother breast milk feeding sessions (direct or expressed) in the last 24 hours
时间窗: Daily till the discharge of newborn or 14 days after admission whichever is earlier
4. Mean number of breast milk expression sessions in the last 24 hours
时间窗: Daily till the discharge of newborn or 14 days after admission whichever is earlier
5. Maternal self-efficacy or confidence (different tools for those who expressed and those who fed directly at the breast)
时间窗: Daily till the discharge of newborn or 14 days after admission whichever is earlier
次要结局
- 1. Mean timing of baby first fed mother breast milk post-NICU admission(2. Management of feeding difficulties)
研究者
Aarti Kumar
Community Empowerment Lab