The Baby Book Project

Phase 1

Recruiting

• Conditions: Neonatal Diseases; Nervous System Diseases

• Registration Number: PACTR202110642756045
• Lead Sponsor: Harry Crossley foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Premature infants born at or before 32 weeks gestational age (but at least 26weeks) with birth weight 1250 grams or less, but more than 750g.
Infants have to be inborn at Tygerberg Hospital or admitted within the first two weeks of life
Infants have to be clinically stable as deemed by attending consultant.
Maternal native language has to be English, Afrikaans or isiXhosa.
Mother has to be literate.
Permanent address in the Western Cape area.

Exclusion Criteria

Infants less than 750g and less than 26 weeks
Prenatally diagnosed brain lesions.
Evidence of perinatal asphyxia and neonatal asphyxia.
Known alcohol or methamphetamine abuse in pregnancy.
Maternal Illiteracy.
SGA: weight less than the tenth percentile on Fenton growth chart.
Grade 3 and 4- intraventricular haemorrhage IVH (Papille classification)
Cystic periventricular leucomalacia (PVL): Grade 4
Dilated lateral ventricular atria above 95th percentile.
Microcephaly: Head circumference less than the third percentile at birth (or more than two standard deviations below the mean on follow-up).
Significant congenital abnormalities, e.g. cardiac lesions that need surgical correction.
Surgical necrotising enterocolitis
Abnormal auditory brainstem response at discharge or follow-up.
Not able to speak English, Afrikaans or isiXhosa.
When more than three episodes of otitis media and middle ear fluid documented before 6-8 months post-term, the infant will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective<br>1.Measuring the effect on fidgety movements and concurrent motor repertoire on the Motor Optimality score (MOS) at 12-16 weeks post-term to assess neurodevelopment.<br>;Measuring the effect of the intervention on maternal-infant interaction as measured on Lynne Murray's Global Rating Score (GRS) and Shared Pleasure Moments (SPMs) at 12 to 16-weeks post-term.<br><br>;Measuring the effect of the intervention on sustained attention with automated eye tracking measuring visual acuity and visuospatial orienting at 6-8 months post-term.

Secondary Outcome Measures

Name	Time	Method
Measuring the effect of the intervention on growth velocity (GV) as measured from birth to discharge. Researchers will also record feeding tolerance, time to reach full feeds, time to regain birth weight, head circumference and time to discharge.;Measuring the effect of the intervention on the Hammersmith Infant Neurological Examination/ HINE score ;Measuring the effect on maternal facial affect recognition and infant facial affect recognition at 6-8 months post-term.;Measuring the effect of the intervention on the Griffith Infant Mental Development Scale (GIMDS) during the first 6-8 months post-term.;Measuring the effect of gender on the study outcomes Motor Optimality score, Global Rating Score, Shared pleasure Moments, Eye tracking, Growth velocity and Griffith Infant Mental development scale (MOS/GRS/SPM/Eye tracking/GV and GIMDS)