Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Skin-to-skin interruptions
研究概览
简要总结
Late-preterm neonates are born between 34 and 36 weeks 7 days gestational age (GA). Neonates born less than 34 weeks GA are at increased risk for morbidity and directly admitted to the Neonatal Intensive Care Unit (NICU). Skin-to-skin contact (SSC) is a standard of care in many units to aid in post-natal transitioning. Current guidelines published by the Neonatal Resuscitation Program (NRP) and American Academy of Pediatrics (AAP) recommend only "vigorous, term" neonates initiate immediate SSC. There is no published data regarding safety or guidelines relating to late-preterm neonates and immediate SSC. Therefore, the investigators hypothesize that post-natal transitioning after immediate SSC within the first hours after birth will be no worse for vigorous, singleton 35 0/7 to 36 6/7 week neonates compared to those who transition to SSC after an initial period of 20 minutes observation under the radiant warmer.
详细描述
Aim: Determine safety of immediate skin-to-skin in vigorous 35 0/7 to 36 6/7 week late-preterm singleton neonates after vaginal delivery compared to current practice of observation under the radiant warmer for 20 minutes.
Organization - University Hospital's Cleveland Medical Center Department of Obstetrics & Gynecology and Rainbow Babies Children's Hospital Department of Neonatology will be the only participating members.
Study Design - This is a prospective, randomized-control, and equivalence study. The cohort of subjects that will be recruited for this study will include singleton neonates born via vaginal delivery to Mothers at 35 0/7 to 36 6/7 weeks GA in UH MacDonald Women's Hospital Labor & Delivery Hospital.
Recruitment Procedures
- Recruitment will occur at UH MacDonald Women's Hospital
- Mothers who meet the inclusion criteria will be tracked in the EMR at time of admission to the Labor & Delivery Unit.
- Informed consent will be obtained by members of the research team.
- Consenting process will occur at the time of Mother's admission to the Labor & Delivery Unit.
- Consent will be obtained in Mother's room.
- Mother will not be consented if sedated, under distress from laboring process, or clinically unstable per Labor & Delivery Team.
- A copy of the consent will be given to the Mother, a copy kept in a locked, secure office for research collection purposes, and a copy will be scanned into the electronic medical record (EMR).
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singletons born 35 0/7 to 36 6/7 weeks GA via vaginal delivery
- •Vigorous - crying, good respiratory effort, good tone
- •No major congenital malformation
排除标准
- •Neonates born < 35 weeks GA
- •Non-vigorous or needing resuscitation soon after birth
- •Known major congenital malformation
- •Maternal sedation or if clinically unstable per Labor & Delivery team
研究组 & 干预措施
Skin Group
Pulse oximeter probe is placed on right wrist of vigorous neonate after vaginal birth. If randomized to skin group, neonate will initiate skin-to-skin contact after umbilical cord is cut and dried with warm blankets on Mother's abdomen. Length of monitoring will be for first hour of life.
干预措施: Skin Group (Other)
Warmer Group
Pulse oximeter probe is placed on right wrist of vigorous neonate after vaginal birth. If randomized to warmer group, neonate will initiate skin-to-skin contact after 20 minutes of observation under the radiant warmer. Length of monitoring will be for first hour of life.
干预措施: Warmer Group (Other)
结局指标
主要结局
Skin-to-skin interruptions
时间窗: First hour of life
The investigators will track the number of times skin-to-skin contact is disrupted within the first hour of life and document reasons for interruption.
次要结局
- Risks for late-preterm neonates(Length of hospital stay)
研究者
Rebecca Walsh
Neonatology Fellow, MD
University Hospitals Cleveland Medical Center