Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy: a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Length of hospital stay
研究概览
简要总结
Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation. Many neonatal units do not use enteral feeding during TH, in fear of increased risk of complications. Withholding enteral feedings during TH lacks supporting evidence. The aim of the study is to determine if enteral feeding during TH in patients with HIE is safe and assess its effects. Investigators will perform multicenter randomized controlled study in level III neonatal intensive care units on infants qualified for TH. Infants will be randomized into 2 groups: (1) unfed during 72 hours of TH; (2) fed group, which will start receive enteral feeding with mother milk or human donor breast milk at 10 ml/kg/day during first day of TH, 20 ml/kg/day during second day, 30 ml/kg/day during third day. The primary outcome will be (1) combined necrotizing enterocolitis or death, (2) length of hospital stay. The secondary outcomes will be (1) time to full enteral feeding, (2) late-onset sepsis, (3) Test of Infant Motor Performance scoring, (4) MRI scoring, (5) MR spectroscopy parameters.
详细描述
Investigators will perform a multi-centre, randomized, parallel-arm study in level III neonatal intensive care units in southern part of Poland (Małopolska - 3 units and Podkarpacie - 2 units) on infants qualified for TH. A randomization of subjects will be done via computer software (Redcap Randomization Module). Participants will be allocated to an intervention (TH+human milk (HM)) or control (TH) group. In both groups standard therapeutic hypothermia to rectal temperature of 33,5 C will be performed by 72 hours, including during neonatal transport for outborn babies, starting within 6 hours after birth. Investigators will use mother milk or human donor breast milk, if mother milk is not available.
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Inclusion criteria:
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35 weeks or more gestational age
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< 6 hours post birth
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Any of the following:
- Metabolic or mixed acidosis with a pH of ≤7.0 or a base deficit ≥16 mmol/L in an umbilical cord blood sample or any blood obtained within first hour after birth
- 10-minute Apgar score of ≤5
- Ongoing resuscitation initiated at birth and continued for ≥10 minutes
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Moderate to severe encephalopathy on clinical examination, using a Thompson HIE score ≥ 7
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Signed informed consent by parent
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Exclusion criteria:
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Critical general condition;
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Aneuploidies (13 th , 18 th , 21 st );
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Birth weight <1800 g;
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Severe congenital defects with poor prognosis;
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Severe mechanical head injuries;
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Congenital malformations of digestive system (esophageal atresia, duodenal atresia, gastroschisis, omphalocele, anal atresia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35 weeks or more gestational age
- •< 6 hours post birth
- •Any of the following:
- •Metabolic or mixed acidosis with a pH of ≤7.0 or a base deficit ≥16 mmol/L in an umbilical cord blood sample or any blood obtained within first hour after birth
- •10-minute Apgar score of ≤5
- •Ongoing resuscitation initiated at birth and continued for ≥10 minutes
- •Moderate to severe encephalopathy on clinical examination, using a Thompson HIE score ≥ 7
- •Signed informed consent by parent
排除标准
- •Critical general condition
- •Aneuploidies (13 th , 18 th , 21 st )
- •Birth weight <1800 g
- •Severe congenital defects with poor prognosis
- •Severe mechanical head injuries
- •Congenital malformations of digestive system (esophageal atresia, duodenal atresia, gastroschisis, omphalocele, anal atresia)
结局指标
主要结局
Length of hospital stay
时间窗: assessed from day of birth until discharge from hospital, an average of 8 weeks
Combined Necrotizing enterocolitis or death
时间窗: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, during hospital stay, an average of 8 weeks
Necrotizing enterocolitis will be defined by the modified Bell's staging criteria (stage II or stage III)
次要结局
- Time to full enteral feeding(assessed from day of birth until discharge from hospital, an average of 8 weeks)
- Late-onset sepsis(assessed from day of birth until discharge from hospital, an average of 8 weeks)
- Test of Infant Motor Performance scoring(assessed from day of birth until discharge from hospital, an average of 8 weeks)
- MRI scoring(assessed until the end of the third month of life)
- MR spectroscopy parameter(assessed until the end of the third month of life)
研究者
Viktoryia Parfenchyk
Principal Investigator, Physician
Nutricia Foundation