Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Expression of Neonatal Primitive Reflexes (RNP) are modified by administration of Oxytocin during delivery.
研究概览
简要总结
The aim of this study was to assess whether administration of oxytocin intrapartum (Oxt) has any effect on Neonatal Primitive Reflexes (RNP) and if dose dependent. The secondary objective is to assess the effects on exclusive breastfeeding at 3 months
详细描述
Patients and Methods Prospective case-control study performed in a tertiary hospital. Cases: mother-child dyads in which Oxt had been administered during the birth process (n = 53). Controls: mother-child dyads without Oxt (n = 45). The RNP were recorded with a camcorder in biological nurturing position. An observer blinded to the group and the dose of Oxt codified the RNP (reach/not reached). To assess the type of breastfeeding telephone call was made at 3 months old RN.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy singleton term infant delivered vaginally with Apgar at 5 min> 7;
- •Expressed desire to administer during pregnancy breastfeeding;
- •Signed informed consent
排除标准
- •Preterm neonate;
- •Fetal chromosomal or other abnormalities diagnosed in utero to modify their adaptation to extrauterine environment;
- •Hospitalization of the mother in ICU;
- •Hospitalization in the following 48 hours neonate at birth;
- •Wish to artificial feeding before parturition;
- •Language difficulties;
- •Completion of caesarean delivery
研究组 & 干预措施
Not exposed to oxytocin
Mother-child dyads in which Oxt had not been administered during the birth process
干预措施: Oxytocin (Drug)
结局指标
主要结局
Expression of Neonatal Primitive Reflexes (RNP) are modified by administration of Oxytocin during delivery.
时间窗: 72 hours
Neonatal Primitive Reflexes studied were: 1) Endogenous: hand to mouth, extension / flexion of fingers, mouth open, tongue extrusion, arm circular motion, circular motion of the leg, flex foot / hand, 2) Antigravity: raise the head, 3) Motors: turn your head, nod, plantar pressure, Babinski, and 4) Rhythmic: suction, jaw movement and swallowing. An observer, blinded to the study group and the dose administered of Oxytocin, valued recordings, analyzing the state of consciousness at the beginning of the recording as Brazelton scale and form RNP dichotomous coding (achieved / not achieved).
次要结局
- Oxytocin intrapartum may have adverse influence on exclusive breastfeeding at 3 months.(6 months)
研究者
Miguel Angel Marin Gabriel
MD Pediatrics-Neonatology
Puerta de Hierro University Hospital