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临床试验/NCT01131156
NCT01131156已完成不适用

Prevention of Postpartum Smoking Relapse in Mothers of Infants in the Neonatal Intensive Care Unit

Loma Linda University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2009年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Duration of smoke-free status

研究概览

简要总结

The investigators hypothesized that an enriched focus on mother-infant bonding during a newborn's hospitalization in the Neonatal Intensive Care Unit would reduced the rate maternal postpartum smoking relapse and would prolong the duration of breastfeeding in mothers who had quit smoking during or just prior to pregnancy.

详细描述

Mothers of newborns admitted to the Neonatal Intensive Care Unit (NICU), who had quit smoking during or just prior to pregnancy where randomized to either the Standard of Care or Smoking Relapse Prevention group. Mothers in both groups were encouraged to remain smoke free following the birth of their babies and were given routine lactation support for breastfeeding during their babies' hospitalization in the NICU. Mothers in the Smoking Relapse Prevention group were also given the study intervention, which was enhanced support for maternal-infant bonding by providing information about their newborn's behaviors using books, DVDs, and handouts that were appropriate for their baby's gestational age and by encouraging frequent skin-to-skin holding.

Primary outcomes included duration of smoke-free status and duration of breastfeeding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 1 Week(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Who had quit smoking during pregnancy or within one year prior to pregnancy
  • •Who had newborns < 1 week old at the time of admission to our NICU.

排除标准

  • •Who were smokers at the time of delivery
  • •Whose infant's length of stay < one week
  • •Who were not available (jail, adoption)
  • •Who had a history of drug use
  • •Who did not speak English

结局指标

主要结局

Duration of smoke-free status

时间窗: 8 weeks postpartum

Duration of maternal smoke-free status during the first 8 weeks postpartum following delivery of newborn infant

Duration of breastfeeding

时间窗: 8 weeks postpartum

Duration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raylene Phillips, MD

Medical Doctor

Loma Linda University

研究点 (1)

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