Neonatal Diseases
Conditions
Interventions
Standard care
Sponsors
Mbale Clinical Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: • Admission weight 800g to <1500g • Admission age < 24 hours • Mother +/- father who can understand English, Luganda, Lugwere, Ateso or Lumasaba • Mother +/- father who are willing and able to give written informed consent for participation of their infant in the study. • Mother aged 15 years or above
Exclusion criteria
Exclusion criteria: • Mother or father are not willing or are unable to give written, informed consent for participation of their infant in the study within 48 hours of admission to the NNU • Second or later birth order or a multiple pregnancy, when the first or an earlier birth order infant is eligible for participation • Infants with major congenital abnormality e.g. gastroschisis, cyanotic heart disease, upper airways abnormality • Critically ill infants at time of enrollment: Babies with apnoeas requiring frequent stimulation or bag mask ventilation; shock (heart rate >200 beats per minute and/or Mean Arterial Pressure 5% body surface area likely to produce a defect in epidermal barrier function. • Mother and father unwilling to come back to Mbale RRH for follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ·In-hospital mortality up to 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| · Mortality rates at day 7 and 28, and 12 months age ;Incidence-density of neonatal sepsis defined as clinical features of infection with either a positive blood culture and/or elevated CRP > 10 at 0 and/or 36 hours from suspicion of infection ;Weight (WAZ) and head circumference (HCZ) using Intergrowth-21 ;· Growth velocity from birth to 28 days or discharge if earlier (g/kg/d and Delta z-score) ;· Anthropometric indices (WLZ, LAZ, WAZ, HCZ) using WHO child growth standards at term, 6, 12 months corrected age ;· Skin condition scores and barrier function (transepidermal water loss) at day 1, 3, 7, 21, 28 (or discharge if earlier) [66] · ;Development according to the GSED at 6, 12 months corrected age reported as a DAZ-score ·; Neurological performance using Hammersmith Infant Neurological Examination score at 12 months corrected age, defined as <73 (suboptimal), and <65 (high probability of cerebral palsy) · ;Hearing impairment at 6 months corrected age ;Incidence-density and severity of hypothermia <35.5C until 72 hours of age – axillary temperature measures every 4 hours.;Incidence and severity of retinopathy of prematurity using ophthalmic examinations starting at 28 days postnatal age and continuing every 1-2 weeks until term corrected age. ;Incidence and severity of intraventricular haemorrhage on cranial ultrasound before 28 days of age (Papile grading) ;Maternal depression and anxiety at discharge of infant, and 6 weeks post partum (EPDS and GAD-7) [67, 68] ;· Maternal-Neonatal Interaction at discharge and 6 weeks post part (Perceived Maternal Parenting Self Efficacy, PMP-S-E) [69, 70] ;Pre-intervention acceptability of the intervention and readiness by healthcare workers and caregivers (qualitative assessment) ;Post-intervention acceptability of the intervention by healthcare workers and caregivers (qualitative assessment) | — |
Countries
Uganda
Contacts
Public ContactDavid Mukunya
Associate Professor Busitema University
Outcome results
None listed