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

NCT ID: NCT01131156

Last Updated: 2014-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-06-30

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.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Smoking Relapse Prevention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Maximum Eligible Age: 1 Week
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Pediatrics

OTHER

Sponsor Role: collaborator

Flight Attendant Medical Research Institute

OTHER

Sponsor Role: collaborator

March of Dimes

OTHER

Sponsor Role: collaborator

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Raylene Phillips, MD

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

T. Allen Merritt, MD, MHA

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University, School of Medicine

Locations

Loma Linda University Children's Hospital

Loma Linda, California, United States

Countries

United States

Other Identifiers

58108

Identifier Type: -

Identifier Source: org_study_id