Effect of Human milk fortification on neuromotor outcomes in preterm infants: one year hospital based randomised control trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Jawaharlal Nehru Medical College KLE University Belagavi
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To assess the effect of Human milk fortification on neuromotor outcomes in preterm infants using General Movement Assessment (GMA).
概览
简要总结
In this study we will be seeing the effect of human milk fortification on neuromotor outcomes in preterm infants. Very preterm infants are at high risk for range of complications. Beyond survival, a major concern for this population is the increased risk of long-term neurodevelopment impairments, including cognitive delays, motor dysfunction, and behavioural issues.
Due to their limited physiological reserves and high nutritional demands, very preterm infants require specialised care in neonatal intensive care unit (NICU). Early interventions, including optimal nutritional strategies, are essential to support growth, organ maturation, and neurodevelopment.Thus, optimisation of the nutritional care of preterm infants has a key role in improving neurodevelopment outcomes and it is a priority. However, the nutrient composition of human milk alone is often insufficient to meet the high metabolic demands of preterm infants, necessitating human milk fortification to ensure adequate weight gain, linear growth and neurodevelopment outcomes. Early prediction of cerebral palsy and other neurodevelopmental delays in this population is essential to enable timely intervention, optimize outcomes, and support families.
General Movement Assessment (GMA) serves as a critical tool for evaluating early neuromotor function in preterm infants. Compared to other tools like Bayley scales or HINE, GMA offers the distinct advantage of being a non-invasive, cost-effective, highly predictive method that can be used as early as neonatal period. Studies have shown that the absence or abnormality of these moments can predict cerebral palsy with over 90% accuracy- well before traditional assessments like Bayley and HINE.
The infants enrolled into this study will be assessed for neuromotor outcomes at the time of discharge using General Movement Assessment (GMA) by trained personnel. This will be done either by direct observation or by video recording for the purpose. Movements will be assessed, and scores will be given as normal and abnormal (poor-repertoire, cramped-synchronised, chaotic movements).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Very Low Birth Weight (less than or equal to 1.5kg) or very preterm (28-32 weeks) infants admitted to NICU at study facility less than 24 hours after birth for inborn infants and upto 48 hours for out-born infants.
- •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 randomisation: Infant receiving at least 60 mL per kg in per day of human milk (On Day 10 of life)
- •Willing to participate in the study.
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 (GI) tract anomalies, hydrocephalus, necrotising enterocolitis]
- •Severe birth asphyxia
- •Unknown date of birth and unknown gestational age.
结局指标
主要结局
To assess the effect of Human milk fortification on neuromotor outcomes in preterm infants using General Movement Assessment (GMA).
时间窗: At the time of discharge from hospital
次要结局
- To assess the effect of risk factors like birth weight, birth length, gestation, gender and weight gain on neuromotor function in the study subjects.(The infants will be monitored from the date of admission till the date of discharge.)
研究者
Dr Shreya Katariya
Jawaharlal Nehru Medical College KLE University