Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202110642756045 Date of Approval: 20/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Baby Book Project
Official scientific title The Baby Book Project. Can nursery rhyme reading by mothers, during the hospital stay, support neurodevelopment and maternal-infant interaction in premature infants?
Brief summary describing the background and objectives of the trial Thirty per cent of infants born prematurely suffer from a language developmental disorder. There is a growing body of evidence that the premature brain is amenable to sensitive sensory stimulation. The auditory system's development is dependent on experience. In the acquisition of language, early stimulation is likely more critical. The intra-uterine environment nurtures early language exposure. High-frequency sounds are filtered out, and maternal heartbeat and voice are enhanced. A foetus has a substantial capacity for auditory learning and memory while in utero. Infants can distinguish the maternal voice, native language and nursery rhymes read by the mother at term. The human foetus can perceive and react to sensory information starting at approximately week 23-26 of life. It is currently unknown if the brain of the premature baby can benefit developmentally from gentle live auditory stimulation. Evidence from prospective trials, randomised control studies or quasi-experimental design, with post neurodevelopmental outcomes, is lacking. Objectives: In a sample of premature infants, compared to a non-exposed group, those exposed to maternal live daily nursery rhyme reading will have more advanced neurodevelopment as measured by:(1) GMs at 12-16 weeks post-term (FMs) and concurrent movements on the MOS (2)HINE at 12-16-weeks post-term (3) GIMDS during first 6-8 months post-term and (4) better eye tracking as measured by 6-8 months post-term and improved maternal-infant interaction as measured by Global Rating Score (GRS) and Shared Pleasure Moments (SPM) at 12 to 16-weeks post-term and maternal/infant facial affect recognition at 6 to 8-months post-term.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) BBP
Disease(s) or condition(s) being studied Neonatal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/04/2021
Actual trial start date 01/04/2021
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 320
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
S1909178 PhD HREC 2 University of Stellenbosch
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Life maternal voice exposure via daily reading of nursery rhymes Daily voice exposure through nursery rhyme reading or singing for 15 to 30- minutes From within the first two weeks after the birth until discharge from the hospital. Duration of hospitalisation Daily sessions of life maternal voice exposure through nursery book (in mother's native language) reading or singing for 15 to 30 minutes. 160
Control Group Routine Kangaroo Mother Care. Books given at 12 weeks post term follow up. Standard Kangaroo Mother Care daily. Information (video's and a session) will be offered to mothers to explain the importance of speaking to their babies. For the duration of hospitalisation. Routine KMC & Communication information 160 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. Infant: 0 Month-23 Month,New born: 0 Day-1 Month 2 Day(s) 14 Day(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/02/2021 Health Research Ethic committee 2 University of Stellenbosch
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Dr, Avenue Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary objective 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. At 12-16 weeks post-term about 5-7 months after birth
Primary Outcome 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. 12 to 16 weeks post-term about 5-7 months after birth/enrollment
Primary Outcome 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. At 6 to 8 months post term About 8-11 months after birth/enrollment
Secondary Outcome 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. At discharge from hospital. Usually about 2 to 3 months after birth.
Secondary Outcome Measuring the effect of the intervention on the Hammersmith Infant Neurological Examination/ HINE score At 12-16 weeks post-term which is usually at 5 to 7 months after birth
Secondary Outcome Measuring the effect on maternal facial affect recognition and infant facial affect recognition at 6-8 months post-term. At 6 to 8 months post term. About 8-11 months after birth
Secondary Outcome Measuring the effect of the intervention on the Griffith Infant Mental Development Scale (GIMDS) during the first 6-8 months post-term. At 6 to 8 months post term About 8-11 months after birth/enrollment
Secondary Outcome 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) At discharge, 12-16 weeks post-term and 6 to 8 months post-term
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Hospital Frabcie van Zijl Dr, Avenue Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Harry Crossley Foundation Francie van Zijl Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Harry Crossley foundation Francie van Zijl Dr, Avenue Cape Town 7505 South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Marlette Burger Francie van Zijl Dr, Avenue Cape Town 7505 South Africa
Dr Netta van Zyl Francie van Zijl Dr, Avenue Cape Town 7505 South Africa
Dr Christa Einspieler christa.einspielermedunigraz.at Grasse 06131 Austria
Prof DJH Niehaus Wellway Park 5 Somerset Crescent Durbanville Cape Town 7550 South Africa
J Leppanen 401 WKennedy Blvd Tampa 33606 United States of America
Martin Kidd Van der Sterr Building Bosman street stellenbosch 7599 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jacomina Du Preez miemie@sun.ac.za +27833258783 12 Welgevallen street Dalsig
City Postal code Country Position/Affiliation
Stellenbosch 7600 South Africa Neonatal Consultant at the University of Stellenbosch
Role Name Email Phone Street address
Public Enquiries Netta Van Zyl jivz@sun.ac.za +27834147483 Francie van Zijl Dr, Avenue
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Neurodevelopmentalist
Role Name Email Phone Street address
Scientific Enquiries Johan Smith js7@sun.ac.za +27832702301 Francie van Zijl Dr, Avenue
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Supervisor University of Stellenbosch
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available including the data dictionary that will be kept on REDCap (Research Electronic Data Capture). Individual participant data that underlie the results reported in the articles will be available for sharing after deidentification. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available for sharing immediately following publication ending 5 years following final article publication. Data will be shared with researchers that provide a methodologically sound proposal. The proposal needs to be approved by the University of Stellenbosch HREC committee. Data will be made available for analysis that achieves the aim of the approved proposal. Proposals should be directed to miemie@sun.ac.za (PI). To gain access, data requesters will need to sign a data access agreement. Data will be available for 5 years at REDCap.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://redcap.sun.ac.za/redcap_v10.6.28/ProjectSetup/index.php?pid=986 No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information