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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131156
• Other study ID #: 58108
• Status: Completed
• Phase: N/A
• First received: May 25, 2010
• Last updated: May 12, 2014
• Start date: May 2009
• Est. completion date: June 2010

Study information

• Verified date: May 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Week

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Loma Linda University Children's Hospital	Loma Linda	California

Sponsors (4)

Lead Sponsor	Collaborator
Loma Linda University	American Academy of Pediatrics, Flight Attendant Medical Research Institute, March of Dimes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Duration of breastfeeding	Duration of breastfeeding during the first 8 weeks postpartum following the birth of newborn infant.	8 weeks postpartum	No