Baby's Breath II protocol development and design: a secondhand smoke exposure prevention program targeting infants discharged from a neonatal intensive care unit.

BACKGROUND: Over one-third of all children live with at least one parent who smokes cigarettes, which is associated with compromised child health. The impact of secondhand smoke exposure (SHSe) in medically fragile infants born prematurely is likely to be much higher. The Baby's Breath II study tests whether a hospital-initiated, motivational-enhancement program will result in less SHSe relative to conventional care in high-risk, low birthweight (LBW) infants discharged from a neonatal intensive care unit (NICU). The design and protocol for the ongoing BBII trial is described. METHODS/
DESIGN: Eligible participants are: (1) primary caregivers (typically mothers) of NICU infants who were born at LBW (<2500g) or ventilated for more than 12h; and (2) who smoke or live with at least one smoker. This randomized controlled trial has two conditions: Motivational interviewing plus incentives (MI+) and conventional care (CC). MI+ participants receive two hospital-based and two home-based counseling sessions, as well as incentives (i.e., prize-based draws) for (a) intervention attendance and (b) biochemical validation (i.e., urine cotinine dipstick) indicative of low or no infant SHSe. Participants in the control group receive conventional education-based care. Assessments are completed at baseline, mid-point, and 1- and 4-months post-intervention. DISCUSSION: This study is the first to determine the efficacy of a brief intervention for reducing SHSe among high-risk, LBW infants discharged from a NICU, with the potential for saving lives and healthcare costs. Strengths, limitations and challenges to the conduct of this trial are discussed.

RCT Entities:   Population Interventions Outcomes