Neurodevelopment of very preterm babies Neonatal Diseases Neurodevelopment of very preterm babies
Conditions
Interventions
Current intervention as of 21/03/2022:
Participants are assigned to either the intervention group or the control group using stratified randomised sampling, the groups are matched for gender, and fami
low vs. average vs. high) as gauged by a parent-report demographics questionnaire administered at the time of recruitment.
Following the pre-intervention assessments, and using the pre-determined seq
Sponsors
Anglia Ruskin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Babies who were born very preterm or nearly so (i.e., = 33 weeks gestation) 2. Babies who are free of major sensory and physical disabilities (e.g., blindness, deafness) 3. Babies who are living within the study catchment area 4. Babies whose parents/caregivers are fluent English speakers 5. Babies who have reached 3 months corrected age 6. Both boys and girls are eligible
Exclusion criteria
Exclusion criteria: 1. Babies with major sensory or physical disability (e.g., blindness, deafness) 2. Babies participating in another clinical trial 3. Babies living outside the project catchment area 4. Babies whose parents are not fluent English speakers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 21/03/2022: Cognitive development is measured using observational tests of exploratory/reaching behaviour at corrected ages of 3 and 4 months, plus parent-report questionnaires at corrected ages of 3, 4, 8 and 15 months. The observational tests were carried out face-to-face in the family home prior to the COVID-19 pandemic but are now being done via Zoom. _____ Previous primary outcome measures: 1. Cognitive development is measured using the Bayley Scales of Infant and Toddler Development 3rd Edition (Bayley-III) at 3 and 15 months of age, and observational tests of exploratory/reaching behaviour at 3, 4, 8 and 15 months of age 2. Motor development is assessed using the Bayley Scales of Infant and Toddler Development 3rd Edition (Bayley-III) at 3 and 15 months of age, and the parent-report Early Motor Questionnaire (EMQ) at 3 and 15 months of age 3. Social development is assessed via habituation tests of attention (measuring infants’ looking time in seconds) to images of human faces and hands at fouur and eight months of age, the Early Social Communication Scales (ESCS) at 15 months of age, and the parent-report Early Childhood Behaviour Questionnaire (ECBQ) at 15 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/03/2022: 1. Parent levels of confidence in interacting with their very preterm baby is measured using the parent-report Interacting with my Premature Infant Questionnaire (IPIQ) at 3 months of age (corrected) 2. Parent levels of stress in interacting with their very preterm baby is measured using the parent-report Parenting Stress Index (PSI) at 15 months of age (corrected) _____ Previous secondary outcome measure: Parent levels of confidence and stress in interacting with their very preterm baby is measured using the parent-report Interacting with my Premature Infant Questionnaire (IPIQ) at three months of age, and the parent-report Parenting Stress Index (PSI) at 15 months of age. | — |
Countries
England, United Kingdom
Contacts
Public ContactRuth Ford
Outcome results
None listed