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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01131156
Enrollment
54
Registered
2010-05-26
Start date
2009-05-31
Completion date
2010-06-30
Last updated
2014-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Keywords

postpartum, smoking, relapse, breastfeeding

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.

Interventions

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.

Sponsors

American Academy of Pediatrics
CollaboratorOTHER
Flight Attendant Medical Research Institute
CollaboratorOTHER
March of Dimes
CollaboratorOTHER
Loma Linda University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of smoke-free status8 weeks postpartumDuration of maternal smoke-free status during the first 8 weeks postpartum following delivery of newborn infant
Duration of breastfeeding8 weeks postpartumDuration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026