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

Not Applicable

Completed

• Conditions: Smoking

• Registration Number: NCT01131156
• Lead Sponsor: Loma Linda University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Duration of smoke-free status	8 weeks postpartum	Duration of maternal smoke-free status during the first 8 weeks postpartum following delivery of newborn infant
Duration of breastfeeding	8 weeks postpartum	Duration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.

Trial Locations

Locations (1)

Loma Linda University Children's Hospital; 🇺🇸 Loma Linda, California, United States