Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 主要终点
- Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy
研究概览
简要总结
Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives.
The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks.
详细描述
The fortification of human milk has been proven to enhance growth without raising the risk of necrotizing enterocolitis, although it may affect feeding tolerance.
Non-invasive techniques like Doppler ultrasonography of the superior mesenteric artery (SMA) and near-infrared spectroscopy (NIRS) have been utilized to evaluate mesenteric blood flow and intestinal oxygenation in preterm infants. Numerous studies have investigated the relationship between SMA flow and feeding intolerance. Findings indicate a significant correlation between increased mean Superior Mesenteric Artery blood flow velocity and early tolerance of enteral feeding. Moreover, research suggests a higher incidence of necrotizing enterocolitis (NEC) in preterm infants exhibiting increased resistance patterns of SMA blood flow velocity on the first day.
Non-invasive monitoring methods offer the ability to assess the impact of various fortification products on intestinal perfusion and oxygenation. This could aid in determining the most suitable fortification product to minimize episodes of feeding intolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
盲法说明
Randomizing the participants to either Bovine-HMF or Human Milk based-HMF will mask the Investigator
入排标准
- 年龄范围
- — 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born <30 weeks' gestation age and less than 1500g of weight.
- •Admitted in Neonatal Intensive Care Unit at Foothills Medical Center
- •Reached full fortified enteral feed and at least 21 days of chronological age.
排除标准
- •Chromosomal or major congenital anomalies
- •Infants diagnosed with NEC.
结局指标
主要结局
Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy
时间窗: 6 hours
Measurements of Near Infrared Spectroscopy are continuous but readings of interest are: before feeding, 30 and 120 minutes after finishing feed.
次要结局
- Changes in SMA doppler end-diastolic velocity (EDV)(6 hours)
- Changes in SMA doppler peak flow velocity (PSV)(6 hours)
- Changes in SMA doppler Porcelout's resistance index (RI)(6 hours)
研究者
Belal Alshaikh
Principal Investigator
University of Calgary