RESUMEN
OBJECTIVE: To describe the parental experience of recruitment and assess differences between parents who participated and those who declined to enroll in a neonatal clinical trial. STUDY DESIGN: This was a survey conducted at 12 US neonatal intensive care units of parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and encephaLopathy (HEAL) trial or who were eligible but declined enrollment. Questions assessed 6 factors of the parental experience of recruitment: (1) interactions with research staff; (2) the consent experience; (3) perceptions of the study; (4) decisional conflict; (5) reasons for/against participation; and (6) timing of making the enrollment decision. RESULTS: In total, 269 of 387 eligible parents, including 183 of 242 (75.6%) of those who enrolled their children in HEAL and 86 of 145 (59.3%) parents who declined to enroll their children in HEAL, were included in analysis. Parents who declined to enroll more preferred to be approached by clinical team members rather than by research team members (72.9% vs 49.2%, P = .005). Enrolled parents more frequently reported positive initial impressions (54.9% vs 10.5%, P < .001). Many parents in both groups made their decision early in the recruitment process. Considerations of reasons for/against participation differed by enrollment status. CONCLUSIONS: Understanding how parents experience recruitment, and how this differs by enrollment status, may help researchers improve recruitment processes for families and increase enrollment. The parental experience of recruitment varied by enrollment status. These findings can guide future work aiming to inform optimal recruitment strategies for neonatal clinical trials.
Asunto(s)
Toma de Decisiones , Padres/psicología , Selección de Paciente , Estudios Transversales , Humanos , Lactante , Recién Nacido , Unidades de Cuidado Intensivo Neonatal/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto , Encuestas y CuestionariosRESUMEN
OBJECTIVES: To determine the incidence, timing, progression, and risk factors for intracranial hemorrhage (ICH) in infants 240/7 to 276/7 weeks of gestational age and to characterize the association between ICH and death or neurodevelopmental impairment (NDI) at 2 years of corrected age. STUDY DESIGN: Infants enrolled in the Preterm Erythropoietin Neuroprotection Trial had serial cranial ultrasound scans performed on day 1, day 7-9, and 36 weeks of postmenstrual age to evaluate ICH. Potential risk factors for development of ICH were examined. Outcomes included death or severe NDI as well as Bayley Scales of Infant and Toddler Development, 3rd Edition, at 2 years of corrected age. RESULTS: ICH was identified in 38% (n = 339) of 883 enrolled infants. Multiple gestation and cesarean delivery reduced the risk of any ICH on day 1. Risk factors for development of bilateral Grade 2, Grade 3, or Grade 4 ICH at day 7-9 included any ICH at day 1; 2 or more doses of prenatal steroids decreased risk. Bilateral Grade 2, Grade 3, or Grade 4 ICH at 36 weeks were associated with previous ICH at day 7-9. Bilateral Grade 2, any Grade 3, and any Grade 4 ICH at 7-9 days or 36 weeks of postmenstrual age were associated with increased risk of death or severe NDI and lower Bayley Scales of Infant and Toddler Development, 3rd Edition, scores. CONCLUSIONS: Risk factors for ICH varied by timing of bleed. Bilateral and increasing grade of ICH were associated with death or NDI in infants born extremely preterm.
Asunto(s)
Hemorragias Intracraneales/mortalidad , Trastornos del Neurodesarrollo/epidemiología , Preescolar , Femenino , Humanos , Lactante , Recien Nacido Extremadamente Prematuro , Recién Nacido , Enfermedades del Prematuro , Hemorragias Intracraneales/diagnóstico por imagen , Masculino , Trastornos del Neurodesarrollo/etiología , Prevalencia , Factores de Riesgo , Índice de Severidad de la Enfermedad , UltrasonografíaRESUMEN
BACKGROUND: Neonatal mortality comprises an increasing proportion of childhood deaths in the developing world. Essential newborn care practices as recommended by the WHO may improve neonatal outcomes in resource limited settings. Our objective was to pilot a Helping Babies Breathe and Essential Care for Every Baby (HBB and ECEB) implementation package using HBB-ECEB training combined with supportive supervision in rural Nicaragua. METHODS: We employed an HBB-ECEB implementation package in El Ayote and Santo Domingo, two rural municipalities in Nicaragua and used a pre- and post- data collection design for comparison. Following a period of pre-intervention data collection (June-August 2015), care providers were trained in HBB and ECEB using a train-the- trainer model. An external supportive supervisor monitored processes of care and collected data. Data on newborn care processes and short-term outcomes such as hypothermia were collected from facility medical records and analyzed using standard run charts. Home visits were used to determine breastfeeding rates at 7, 30 and 60 days. RESULTS: There were 480 institutional births during the study period (June 2015-June 2016). Following the HBB-ECEB implementation package, cord care improved (pre-intervention median 66%; post-intervention shift to ≥85%) and early skin-to-skin care improved (pre-intervention median 0%; post-intervention shift to ≥56%, with a high of 92% in June 2016). Rates of administration of ophthalmic ointment and vitamin K were high pre-intervention (median 97%) and remained high. Early initiation of breastfeeding increased with a pre-intervention median of 25% and post-intervention shift to ≥28%, with a peak of 81% in June 2016. Exclusive breastfeeding rates increased short-term but were not significantly different by 60-days of life (9% pre-intervention versus 21% post-intervention). CONCLUSIONS: The implementation of the HBB-ECEB programs combined with supportive supervision improved the quality of care for newborns in terms of cord care, early skin-to-skin care and early initiation of breastfeeding. The rates of administration of ophthalmic ointment and vitamin K were high pre- intervention and remained high afterwards. These findings show that HBB-ECEB programs implemented with supportive supervision can improve quality of care for newborns.