Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Implementation research of an in-facility and community supportive care package
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 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
The "LIFT-UP’’ study focuses on addressing the challenges posed by low birth weight (LBW), very low birth weight (VLBW) and preterm gestation newborns, particularly in Low and Middle-Income Countries (LMICs) like India and some of the African countries etc. These babies are more likely to have health problems, and it can affect their growth and development.
This research has been initiated by Ariadne Labs at the Harvard School of Public Health (HSPH), and will be conducted in India (UP and Karnataka), Malawi, and Tanzania. The overarching study has multiple objectives, and the study in UP will be focused on the following: (i) To refine and evaluate a co-designed specialized “infacility feeding support plus†package (lactation/ human milk feeding support and management with KMC & WASH) along with its delivery approach to LBW or preterm infants and their families through health providers in routine NICU facility settings. (ii) To refine and evaluate a co-designed, scalable specialized transition-to-home “community feeding support plus†package (lactation and feeding counseling and support with KMC and WASH) along with its delivery approach to mothers and their LBW or preterm infants discharged from NICU facilities in routine community settings through existing community health workers.
Specifically, our goal through this implementation research would be the development of an effective and scalable package that can be implemented within facility and community settings to support the comprehensive care of preterm/ LBW infants throughout the facility-community continuum. While Objective 1 of the study will be conducted simultaneously across India (UP), Malawi and Tanzania and elements of the co-designed and refined package will be harmonized across the three sites, Objective 2 of the study will only be conducted in India (UP). In India, the study will be conducted in partnership with medical colleges with level-3 hospitals in three districts. This is an implementation research, and the co-developed facility and community-based feeding support strategies will be concurrently evaluated and optimized to improve provider behaviors, and maternal and family practices to achieve optimal feeding and care of newborns and ensure its feasibility and acceptability.
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 5.Women (mothers) who are 18+ years of age 6.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: 1. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). | 2. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). | 3. Daily till 14 days or discharge (Whichever is earlier). | 4. Daily till 14 days or discharge (Whichever is earlier). | 5. Last day i.e. 14th day or on the day of discharge 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: 1. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). | 2. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). | 3. Daily till 14 days or discharge (Whichever is earlier). | 4. Daily till 14 days or discharge (Whichever is earlier). | 5. Last day i.e. 14th day or on the day of discharge whichever is earlier.
3. Mean number of mother breast milk feeding sessions (direct or expressed) in the last 24 hours
时间窗: 1. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). | 2. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). | 3. Daily till 14 days or discharge (Whichever is earlier). | 4. Daily till 14 days or discharge (Whichever is earlier). | 5. Last day i.e. 14th day or on the day of discharge whichever is earlier.
4. Mean number of breast milk expression sessions in the last 24 hours
时间窗: 1. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). | 2. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). | 3. Daily till 14 days or discharge (Whichever is earlier). | 4. Daily till 14 days or discharge (Whichever is earlier). | 5. Last day i.e. 14th day or on the day of discharge 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: 1. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). | 2. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). | 3. Daily till 14 days or discharge (Whichever is earlier). | 4. Daily till 14 days or discharge (Whichever is earlier). | 5. Last day i.e. 14th day or on the day of discharge 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