ABSTRACT
OBJECTIVE: To describe parents' motivations for and against participation in neonatal research, including the views of those who declined participation. STUDY DESIGN: We performed 44 semi-structured, qualitative interviews of parents approached for neonatal research. Here we describe their motivations for and against participation. RESULTS: Altruism was an important reason parents chose to participate. Some hoped participation in research would benefit their infant. Burdens of participation to the family, such as transportation to follow up (distinct from risks/burdens to the infant), were often deciding factors among those who declined participation. Perceived risks to the infant were reasons against participation, but parents often did not differentiate between baseline risks and incremental risk of study participation. Concerns regarding their infant being treated like a "guinea pig" were common among those who declined. Finally, historical abuses and institutional racism were reported as important concerns by some research decliners from minoritized populations. CONCLUSIONS: Within a diverse sample of parents approached to enroll their infant in neonatal research, motivations for and against participation emerged, which may be targets of future interventions. These motivations included reasons for participation which we may hope to encourage, such as altruism. They also included reasons against participation, which we may hope to, as feasible, eliminate, mitigate, or at least acknowledge. These findings can help clinical trialists, regulators, and funders attempting to improve neonatal research recruitment processes.
ABSTRACT
OBJECTIVE: To compare brain magnetic resonance imaging (MRI) biomarkers and neurodevelopmental test scores in infants born preterm with and without prenatal opioid exposure (POE). STUDY DESIGN: We examined 395 preterm infants (≤32 weeks gestational age) who had term-equivalent brain MRIs, composite scores from the Bayley Scales of Infant and Toddler Development-III at 2 years corrected age, and POE data. MRI parameters included total/regional brain volumes and severe punctate white matter lesions (PWMLs). We conducted bivariable analysis and multivariable logistic regression analyses. RESULTS: The mean ± SD gestational age was 29.3 ± 2.5 weeks; 35 (8.9%) had POE and 20 (5.1%) had severe PWML. Compared with unexposed infants, those with POE exhibited higher rates of severe PWML (17.1% vs 3.9%, respectively; P = .002); findings remained significant with an OR of 4.16 (95% CI, 1.26-13.68) after adjusting for confounders. On mediation analysis, the significant relationship between POE and severe PWML was not indirectly mediated through preterm birth/gestational age (OR, 0.93; 95% CI, 0.78-1.10), thus suggesting the association was largely driven by a direct adverse effect of POE on white matter. In multivariable analyses, POE was associated with a significantly lower score by -6.2 (95% CI, -11.8 to -0.6) points on the Bayley Scales of Infant and Toddler Development-III Motor subscale compared with unexposed infants. CONCLUSIONS: POE was associated with severe PWML; this outcome may be a direct effect of POE rather than being mediated by premature birth. POE was also associated with worse motor development. Continued follow-up to understand the long-term effects of POE is warranted.
Subject(s)
Premature Birth , White Matter , Infant , Pregnancy , Female , Infant, Newborn , Humans , Child, Preschool , Infant, Premature , Analgesics, Opioid/adverse effects , Brain/diagnostic imaging , Brain/pathology , White Matter/diagnostic imaging , Gestational AgeABSTRACT
In this retrospective cohort study, we assessed the incidence of torticollis in infants with a history of neonatal abstinence syndrome. Understanding the elevated risk of torticollis in this population is important for early identification and treatment.
Subject(s)
Neonatal Abstinence Syndrome/complications , Prenatal Exposure Delayed Effects/epidemiology , Torticollis/epidemiology , Cohort Studies , Female , Humans , Incidence , Infant , Infant, Newborn , Male , Pregnancy , Retrospective Studies , Risk Factors , Torticollis/etiology , United States/epidemiologyABSTRACT
Magnetic resonance imaging of the brain was performed in 26 preterm infants with necrotizing enterocolitis (NEC) or spontaneous intestinal perforation at term equivalent age. Infants with surgical NEC or spontaneous intestinal perforation had significantly more brain injury on magnetic resonance imaging compared with infants with medical NEC, even after adjustment for confounders.
Subject(s)
Brain Diseases/diagnosis , Brain/pathology , Enterocolitis, Necrotizing/diagnosis , Infant, Premature, Diseases/diagnosis , Infant, Premature , Intestinal Perforation/diagnosis , Magnetic Resonance Imaging/methods , Brain Diseases/etiology , Enterocolitis, Necrotizing/complications , Enterocolitis, Necrotizing/surgery , Female , Humans , Infant , Infant, Newborn , Infant, Very Low Birth Weight , Intestinal Perforation/complications , Rupture, SpontaneousABSTRACT
The pharmacokinetics of levetiracetam were determined prospectively in 18 neonates with seizures. Neonates were found to have lower clearance, higher volume of distribution, and a longer half-life as compared with older children and adults. Mild somnolence was the only adverse effect.