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OpenTrials
Completed

NCT Number: NCT01131156

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

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.

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Key information

Age range

Up to 1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Children's Hospital

Loma Linda, California, 92354, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mothers:
  • 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.

Exclusion criteria

  • Mothers:
  • 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

Treatment and study plan

Smoking relapse prevention

Behavioral

Mothers were given information about normal newborn behaviors using books, DVDs, and handouts that were appropriate for their baby's gestational age and were also encouraged to participate in frequent skin-to-skin holding of their babies.

Primary outcomes

  1. Duration of smoke-free status

    Time frame: 8 weeks postpartum

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

  2. Duration of breastfeeding

    Time frame: 8 weeks postpartum

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

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • American Academy of Pediatrics
  • Flight Attendant Medical Research Institute
  • March of Dimes

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 26, 2010
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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