Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Randomized Controlled Trial of In-facility Fortification of Human Milk in India and Malawi
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,162
- 试验地点
- 7
- 主要终点
- Length-for-age Z score (LAZ)
研究概览
简要总结
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in the NICU compared to not feeding routinely fortified human milk using the standardized clinical protocol.
The primary research question is: Will VLBW or VPT infants in the NICU who are fed fortified human milk using a standardized feeding protocol have better growth outcomes by facility discharge and at 3 months of age, less illness by discharge, and decreased mortality by discharge and at one month compared to those who are not routinely fed fortified human milk using the same feeding protocol?
详细描述
AIM: To improve feeding and growth outcomes among very low birthweight (LBW; ≤1.5kg) or very preterm (≤32 weeks gestational age) infants admitted to neonatal intensive care units (NICU) in India and Malawi through fortification of human milk.
OBJECTIVE: To evaluate (via individually randomized controlled study) the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very LBW or very preterm infants in the NICU compared to not feeding routinely fortified human milk using the standardized clinical protocol.
STUDY DESIGN This study is a multi-site, multi-country, individually randomized prospective trial among VLBW or VPT infants admitted to the NICU in study facilities who consume human milk and meet eligibility criteria (along with their mothers).
SCREENING AND ENROLLMENT All infants admitted to the NICU and their mothers will be screened for study eligibility. Screening will be performed within 24 hours of birth for inborn infants and within 48 hours of birth for outborn infants. Eligible dyads with the intention to feed human milk [mother's own milk (MOM) or pasteurized donor human milk (PDHM)] whose mothers provide consent will be enrolled into the study.
Once the mother-infant dyad is enrolled and prior to randomization, they will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants (i.e. mother-infant dyads) will not be blinded and will know if the fortification is being provided to the infant as it will be mixed with human milk [MOM or PHDM] in the intervention arm. Clinical research staff will not be blinded as they are preparing and providing the intervention and control feeding assignments. Data collectors and the analysis team will be blinded to study arm assignments to reduce bias in data collection and analysis. These individuals (data collectors and analysis team) will be independent from the clinical study staff who are providing the intervention or control. For data analysis, groups will be labeled with a letter (A vs B) to conceal allocation assignment.
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Very LBW (≤1.5kg)* or very preterm (≤32 weeks) infants admitted to NICU at study facility within 24 hours of birth for in-born infants and up to 48 hours for out-born**
- •Mother and infant alive during screening
- •Mother age 18+ years or 16-17 and married (Malawi only)
- •Lives within catchment areas of the facility (50km)
- •Mother intends to stay in catchment area of the study facility for at least 3 months
- •At randomization: Infant receiving at least 60 mL/kg/day of human milk***
排除标准
- •Lives outside the defined catchment area
- •Congenital abnormalities or acquired conditions that interfere with feeding or placement of nasogastric/orogastric tube [cleft lip/palate, toxoplasmosis, other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, congenital cardiac defect, neural tube defect, gastrointestinal tract anomalies, hydrocephalus, NEC]
- •Severe birth asphyxia
- •Critically ill (i.e. not on enteral feeds)
- •Unknown date of birth and unknown gestational age
结局指标
主要结局
Length-for-age Z score (LAZ)
时间窗: 3 Months
Mean LAZ (SD, range) measured at birth, 2 weeks, 4 weeks and 3 months of age
次要结局
- Length of Stay(From date of randomization until the date of facility discharge or date of death from any cause, whichever came first, assessed up to 3 months of age.)
- Feeding intolerance(From randomization to facility discharge, assessed up to 3 months of age)
- Weight growth velocity(From randomization to facility discharge, assessed up to 3 months of age)
- Length gain(From randomization to facility discharge, assessed up to 3 months of age.)
- Head circumference gain(From randomization to facility discharge, assessed up to 3 months of age)
- Infant mortality(From randomization to 3 months of age)
- Birthweight regain(2 weeks of age)
- Mean weight growth velocity (4 weeks)(From randomization to 4 weeks of age)
- Necrotizing enterocolitis (NEC)(From randomization to facility discharge, assessed up to 3 months of age.)
- Sepsis/possible serious bacterial infection (PSBI)(From randomization to facility discharge, assessed up to 3 months of age)
- Neonatal mortality (4 weeks)(From randomization to 4 weeks of age)
- Sepsis/possible serious bacterial infection (PSBI, 4 weeks)(From randomization to 4 weeks of age)
- Mean weight growth velocity(From randomization to facility discharge, assessed up to 3 months of age.)
- Weight-for-age Z score (WAZ)(3 months of age)
- Weight-for-length Z score (WLZ)(3 months of age)
- Head circumference-for-age Z score (HcAZ)(3 months of age)
- Change in WAZ(From randomization to 3 months of age)
- Change in LAZ(From randomization to 3 months of age)
研究者
Katherine Semrau
Deputy Director, Ariadne Labs & Director, BetterBirth Program; Associate Professor, HSPH
Harvard School of Public Health (HSPH)