Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts - Sucrose Component
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- Infant behavior (emotion regulation)
研究概览
简要总结
Iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain threshold. The opioid system is involved in sucrose's ability to reduce pain and distress during neonatal procedures. Thus, prenatal iron deficiency might affect response to pain and sucrose analgesia. In order to compare response to pain and sucrose during heel stick in neonates with and without iron deficiency, healthy full-term Chinese infants were randomized to receive sucrose or water by syringe beforehand, in conjunction with heel stick for metabolic screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term healthy neonates participating in the Healthy Infant Development RCT (NCT00613717) in the folic acid/early postnatal placebo group and pre- and early postnatal iron-supplemented infants.
排除标准
- •birth weight < 2500 g gestational age ≤ 37 wk major perinatal complications major congenital anomaly multiple birth
研究组 & 干预措施
Sucrose
Newborn infants with ID numbers ending in even numbers offered 2 ml 25% sucrose in distilled water by syringe once in the side of the infant's mouth 2 minutes before heel stick.
干预措施: Sucrose (Other)
Water
Newborn infants with ID numbers ending in odd numbers offered 2ml distilled water by syringe once in the side of the infant's mouth 2 minutes before heel stick.
干预措施: Water (Other)
结局指标
主要结局
Infant behavior (emotion regulation)
时间窗: up to 5 days old
Infant behavior observed included activity level, negative emotionality, alertness and soothability.
次要结局
未报告次要终点