Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Implementation Research of an In-facility and Community Supportive Care Package in India, Malawi and Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 632
- 试验地点
- 9
- 主要终点
- Obj 1: Number of mother's breast milk expression sessions in previous 24 hours
研究概览
简要总结
Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP) aims to improve feeding and growth outcomes among low birthweight (LBW; <2.5kg) or preterm (<37 weeks gestational age) infants admitted to neonatal intensive care units (NICU) in India, Malawi, and Tanzania by (1) supporting the initiation, establishment, and maintenance of maternal lactation and prioritized provision of human milk, Kangaroo Mother Care (KMC) and appropriate water, sanitation and hygiene (WASH) practices; and (2) facilitating feeding counseling at home post-discharge from the facility.
详细描述
AIM: To improve feeding and growth outcomes among low birthweight (LBW; <2.5kg) or preterm (<37 weeks gestational age) infants admitted to NICUs in India, Malawi, and Tanzania by (1) supporting the initiation, establishment, and maintenance of maternal lactation and prioritized provision of human milk, Kangaroo Mother Care (KMC) and appropriate water, sanitation and hygiene (WASH) practices; and (2) facilitating feeding counseling at home post-discharge from the facility.
OBJECTIVES:
To implement and evaluate a co-designed facility-based lactation support/management and feeding counseling + KMC + WASH package (FB-FSP+: Facility-Based Feeding Support Package Plus) for LBW or preterm infants admitted to the neonatal intensive care unit (NICU) and their families from birth to discharge.
To implement and evaluate a co-designed, scalable transition-to-home lactation support/management and feeding counseling + KMC + WASH package (TTH-FSP+: Transition to Home Feeding Support Package Plus) for LBW or preterm infants discharged home from the NICU in India and their mothers/families.
STUDY DESIGN: This multi-site, mixed-methods adaptive implementation science research study will collect quantitative and qualitative data to evaluate the training of providers, the impact of each intervention on key infant feeding, growth, and other health outcomes, the feasibility and acceptability of each intervention for mothers and providers, and the overall experience of mother-infant dyads. Investigators will apply the RE-AIM framework to unpack Reach, Effectiveness, Adoption, Implementation, and Maintenance. Findings will lead to recommendations for iteration and scale-up of the FB- and TTH-FSP+. Investigators will evaluate multiple primary and secondary quantitative outcomes to assess effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OBJECTIVE 1 (FACILITY-BASED)
- •Inclusion criteria
- •Low birthweight (≤2.5kg) or preterm (<37 weeks) infants admitted to NICU at 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 age of majority: Tanzania and India: 18+; Malawi: 16-17 and married OR 18+
- •Healthcare providers
- •Healthcare provider who was trained to deliver the facility-based FSP+
- •Healthcare provider consents for him/herself
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/ orogastric (NG/OG) tube [e.g., cleft lip/palate, toxoplasmosis,other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital cardiac defect, neural tube defect, gastrointestinal (GI) tract anomalies, hydrocephalus, necrotizing enterocolitis]
- •Severe birth asphyxia
- •Unknown date of birth and unknown gestational age
- •OBJECTIVE 2 (TRANSITION-TO-HOME)
- •Inclusion criteria
- •Infants in India-Uttar Pradesh site
- •LBW (<2.5kg) or preterm (<37 weeks) infants discharged from a study facility and fulfilling all objective 1 inclusion criteria (exposed to objective 1 intervention)
- •Lives within catchment areas of study facility (50km)
- •Mother intends to stay in the catchment areas for 3 months post-birth with infant
- •Community providers
- •Community provider who was trained to deliver the transition-to-home FSP+.
- •Community provider consents for him/herself
- •Exclusion criteria
- •Not screened and was not exposed to objective 1 intervention (and meet all eligibility criteria)
- •Lives outside the defined catchment area
- •Mother does not intend to stay in the catchment areas for 3 months post-birth with infant
- •Community providers
- •Community provider who was not trained to deliver the transition-to-home FSP+.
研究组 & 干预措施
Obj 1 Infants receiving facility-based FSP+; Obj 2 infants receiving transition-to-home FSP+
干预措施: Facility-based feeding support package plus (FB-FSP+) (Other)
Obj 1 Infants receiving facility-based FSP+; Obj 2 infants receiving transition-to-home FSP+
干预措施: Transition-to-home feeding support package plus (TTH-FSP+) (Other)
结局指标
主要结局
Obj 1: Number of mother's breast milk expression sessions in previous 24 hours
时间窗: 24 hours
Mean number of sessions in which mother expressed breast milk in the last 24 hours
Obj 2: Growth velocity (g/kg/d)
时间窗: 6 weeks after initial facility discharge
Mean change in infant's weight (growth) calculated in grams/kilogram/day (g/kg/ day) from facility discharge to study discharge
Obj 1 & 2: Maternal breastfeeding self-efficacy/confidence
时间窗: Obj 1 Pilot: On day of facility discharge or at 2 weeks age (whichever is first); Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation; Obj 2: On day of enrollment and 2 weeks and 6 weeks later
Mean score (range 14-70) on validated Breastfeeding Self-Efficacy Scale-Short Form; higher scores reflect more significant levels of breastfeeding self-efficacy
Obj 1: Early initiation of mother's breast milk feeding
时间窗: 1 hour after birth
% infants initiated breast milk feeding within 1 hour of birth
Obj 1: Number of sessions when infant was fed mother's direct or expressed breast milk in previous 24 hours
时间窗: 24 hours
Mean number of mother's breast milk feeding sessions (direct or expressed) in the last 24 hours
Obj 1: Early initiation of mother's first breast stimulation
时间窗: 1 hour after birth
% mothers initiated breast stimulation via first breast milk expression or baby first put to breast within 1 hour of birth
次要结局
- Obj 1: Growth velocity (g/kg/d)(Obj 1 Pilot: Birth to day of discharge or 2 weeks of age (whichever is first); Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation)
- Obj 2: Number of sessions when infant was fed mother's direct or expressed breast milk in previous 24 hours(24 hours)
- Obj 1: 20g/kg/day weight gain(Obj 1 Pilot: Birth to facility discharge or 2 weeks of age; Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation)
- Obj 1 & 2: Management of feeding difficulties(Obj 1 Pilot: Daily referring to the 24 hours assessed from enrollment until facility discharge or 2 weeks of age (whichever occurs first); Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation)
- Obj 1: Time of first feed of mother's breast milk in NICU(From date/time of enrollment until date/time of first documented feed on mother's breast milk in the NICU, assessed up to facility discharge or 14 days, whichever comes first)
- Obj 1 & 2: Infants fed exclusively on mother's own milk in the previous 24 hours(24 hours)
- Obj 1 & 2: Infants receiving KMC in previous 24 hours(24 hours)
- Obj 1 & 2: Infants receiving at least 8 hours of KMC in last 24 hours(24 hours)
- Obj 2: Number of mother's breast milk expression sessions in previous 24 hours(24 hours)
研究者
Katherine Semrau
Deputy Director, Ariadne Labs & Director, BetterBirth Program
Harvard School of Public Health (HSPH)