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

NCT01131156 | Completed DMC

• 1 other identifier: 58108
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

postpartum; smoking; relapse; breastfeeding

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

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.

Eligibility Criteria

• Age: Up to 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead
• American Academy of Pediatrics: collaborator
• Flight Attendant Medical Research Institute: collaborator
• March of Dimes: collaborator

Study Sites (1)

Loma Linda University Children's Hospital

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Smoking; Recurrence; Breast Feeding

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior

Study Officials

• T. Allen Merritt, MD, MHA

  Loma Linda University, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 26, 2010
• Study Start: May 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

US (1)