NCT01745510已完成1 期
Efficacy of Enteral Administration of the Docosahexaenoic Acid on Necrotizing Enterocolitis, Cytokines and Hospital Stay in Preterm Neonates
Coordinación de Investigación en Salud, Mexico1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Necrotizing enterocolitis (NEC)
研究概览
简要总结
- The purpose of this study is to determine whether docosahexaenoic acid is effective in the prevention or reducing severity of necrotizing enterocolitis (NEC) in preterm neonates < 1500 g at birth who are starting enteral feeding.
- if NEC is prevented, this study will measure whether hospital stay is also reduced in neonates who receive Docosahexaenoic acid (DHA)
详细描述
- Preterm neonates with birth weight less than 1500 g are in higher risk to develop NEC.
- NEC is an inflammatory condition that:
- Is the medical urgency most frequent of gastrointestinal tube that requires neonatal intensive care
- may perforate infant´s bowel requiring surgery from 20% to 60% of the cases
- may cause infant's death in 20% to 42% of the cases.
- has no adequate treatment worldwide, therefore prevention is needed
- DHA by enteral feeding has been administrated by our research group to attenuate inflammatory response in septic and surgical neonates.
- Our results showed:
- lower Interleukin(IL)-1 beta in septic neonates, but in surgical neonates, they also showed less IL-6 and anti-inflammatory cytokines IL-10 and IL-1ra, after adjusting by confounders
- increased weight, length and fat mass gain in septic neonates
- decreased organic failures in surgical neonates, and
- lower stay at neonatal intensive care in surgical neonates
DHA has not been used as unique intervention at a high but physiological dose; in addition, our previous results found an anti-inflammatory effect in neonates.Therefore, we expect that preterm infants may have a reduced bowel inflammatory response and lower NEC events and or severity
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Intervention was blinded through assinging a code, printed and saved into opaque envelopes did it by a researcher who did not participate in the fieldwork.
Randomization was carried out through the Random Allocation Software v.1
入排标准
- 年龄范围
- 60 Minutes 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight lower than 1500 g
- •Adequate weight for gestational age
- •Clinically stable to begin enteral feeding
- •Written informed consent by both parents plus the sign of two witnesses
排除标准
- •Clinical and biochemical data of inflammatory response such as body core temperature altered, cardiac and respiratory frequency -low or high according to age-, leucocytosis or leucopenia, taking into account the thresholds reported by Goldstein in Pediatric Critical Care Medicine 2005 Vol 6 N°
- •Persistent bleeding at any level
- •Mother taking n-3 supplements and planning to breastfed
- •Parents who decline the authorization for participating in the study
- •Early discharge to other hospital outside the metropolitan area
- •Persistent vomiting
- •Receiving medication to avoid coagulation
- •Gastrointestinal malformations
结局指标
主要结局
Necrotizing enterocolitis (NEC)
时间窗: Patients will be followed for the duration of hospital stay, an expected average of 6 weeks
Neonates will receive enteral DHA at beginning of their first enteral feeding and NEC will be diagnosed during hospital stay, measured as presence or absence, as well as severity of NEC by Bell's score.
次要结局
- Enteral intolerance(During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks)
- Cytokines Interleukin (IL)-1 beta, Tumoral necrosis factor (TNF)-alpha, IL-6, IL-10(At baseline and a second measurement only if they develop confirmed or severe NEC according to Bell's criteria)
- Hospital stay(The duration of hospital stay, an expected average of 6 weeks)
- Enteral tolerance(During their hospital stay until reach 150 ml/kg/day, in average 2 to 5 weeks)
- Growth velocity in skin folds(Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks)
- Growth velocity in weight(Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks)
- Growth velocity in length and head circumference(Throughout hospital stay as part of nutritional follow-up of the care unit, an expected average of 4 weeks)
研究者
Mariela Bernabe García
Principal investigator
Coordinación de Investigación en Salud, Mexico
研究点 (1)
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