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

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Smoking Relapse Prevention

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of smoke-free status	Duration of maternal smoke-free status during the first 8 weeks postpartum following delivery of newborn infant	8 weeks postpartum
Duration of breastfeeding	Duration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.	8 weeks postpartum

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: March of Dimes; American Academy of Pediatrics; Flight Attendant Medical Research Institute
• Investigators: Principal Investigator: T. Allen Merritt, MD, MHA, Loma Linda University, School of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: May 25, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (Estimate): May 26, 2010

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: relapse; smoking; breastfeeding; postpartum
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 58108