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Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes

Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01726062
Enrollment
360
Registered
2012-11-14
Start date
2012-08-31
Completion date
2018-01-30
Last updated
2018-05-14

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

Conditions

Exposure to Secondhand Smoke in Neonatal Infants

Keywords

Motivational Incentives, Motivational Interviewing, Secondhand Smoke, Neonatal Intensive Care Unit, NICU, High respiratory risk infants, Low birth weight infants, Environmental Tobacco Smoke, Smoking, Contingency management, Infants, Children

Brief summary

A randomized, controlled, parallel group design will be used to test whether a Secondhand Smoke Exposure program initiated in the hospital and completed in the home using motivational interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC) with Neonatal Incentives Care Unit Infants' parents.

Interventions

BEHAVIORALMotivational Interviewing plus Incentives

1. Two hospital-based, face-to-face MI+ sessions 2. Two home-based MI+ sessions 3. Attendance at each session and for the establishment of a household smoking ban at two timepoints post-discharge

BEHAVIORALConventional Care (CC)

Participants in this arm will receive brochures and a brief information meeting in the NICU.

Sponsors

Memorial Hermann Hospital
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Have an infant that is at least 1 week prior to the estimated date of hospital discharge in the NICU at Children's Memorial Hermann Hospital (CMHH) * Report at least one person living in the home who smokes * Agree to attend intervention sessions and to invite other household members * Live within 50 miles of our center * Have access to a telephone.

Exclusion criteria

* Severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol * Inability to read, write, and speak English or Spanish * Inability or unwillingness to provide signed consent for participation * Inability or unwillingness to meet study requirements, including home visits for data collection and intervention purposes.

Design outcomes

Primary

MeasureTime frameDescription
Infant Second-Hand Smoke Exposure via Urine CotinineFollow-up visit 4 months post-treatmentInfant Second-Hand Smoke Exposure (SHSe) measures will be determined via urine cotinine.

Secondary

MeasureTime frameDescription
Secondhand Smoke Exposure outcomesChange from Baseline to the 4 months post-treatment followupPrimary caregiver reports via the Timeline Follow-Back and household air nicotine monitors. Number of cigarettes smoked outdoors vs. indoor and the implementation of household smoking bans will also be assessed. Primary caregivers will complete the SHSe related interviews and self-report questionnaires. Primary caregivers who are smokers will complete measures related to smoking and smoking cessation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026