1. The PANDA Study PORTO-Associated NeuroDevelopmental Assessment Study
RagaMallika Pinnamaneni1,2, Terri Levine3, Fionnuala McAuliffe4,5 Elizabeth Tully6, Fergal Malone1,6 Ruth Grunau3,7,8, Fiona Alderdice3, Adrienne Foran1,2
Rotunda Hospital, Dublin, Ireland
Children’s University Hospital, Temple Street, Dublin, Ireland
Queen’s University Belfast, Northern Ireland
UCD Obstetrics and Gynaecology, School of Medicine and Medical Science
National Maternity Hospital, Dublin, Ireland
Perinatal Ireland
Department of Pediatrics, University of British Columbia, Canada
Child and Family Research Institute, Vancouver, Canada

2. Background
A systematic review of the literature regarding early childhood neurodevelopmental outcomes of children who experienced IUGR has been conducted (Levine et al., in preparation)
Only 4 prospective studies have been conducted assessing the neurodevelopment of these children at age 3
Children who experienced IUGR were more likely to be developmentally delayed and to have lower IQs at age 3, particularly when pregnancies were complicated by pre-eclampsia or when microcephaly persisted
(Villar et al. 1984; Amin et al. 1999; Fattal-Valevski et al. 1999; Many et al.) 2003)

3. Background Continued
There is a great need for increased standardisation in order to clarify the effects of IUGR on neurodevelopmental, psychosocial, and growth outcomes in early childhood
The PANDA study represents an ideal opportunity to evaluate these outcomes in connection with the extensive obstetric and neonatal data gathered in the original PORTO study

4. Study Design
The PANDA study is a multi-centre prospective observational study collecting neurodevelopmental, psychosocial, and growth outcomes for three-year-old children in Ireland who experienced IUGR
Participants will be drawn from the PORTO study

5. Participating Centres

6. Dr. RagaMallika Pinnamaneni’s MD
Terri Levine’s PhD
Analysing psychosocial outcomes at age 3 associated with IUGR
Examining neurodevelopment with the ASQ and the Bayley-III in a subgroup of high-risk children with a low growth trajectory
Examining potential associations with maternal psychological health, IUGR, and infant outcomes at age 3
Supervisors: Professor Fiona Alderdice, Professor Ruth Grunau, and Professor Fionnuala McAuliffe
Funding: Queen’s University Belfast, the Belfast Health and Social Care Trust, and Perinatal Ireland
Dr. RagaMallika Pinnamaneni’s MD
Examining neurodevelopment with the Ages and Stages Questionnaire (ASQ) and the Bayley Scales of Infant and Toddler Development and measuring growth outcomes (height, weight, and occipital-frontal circumference) for a subgroup of high-risk children with abnormal Dopplers Vs normal dopplers
Examining correlation of growth and neurodevelopmental outcomes with MRI findings at term in a subgroup of IUGR infants (StOOPS study)
Supervisor: Dr. Adrienne Foran
Funding: CFFH, C.U.H, Temple Street; Wellcome Trust Strategic Grant and Perinatal Ireland

7. Methodology
N= 1116 original PORTO study contacted for follow-up when 3 years
Participants are contacted by phone in batches according to the child’s birth month to verify current address and contact details
Invitation packs posted
cover letter
study information leaflet
education form, consent form
Ages and Stages Questionnaire
Participants who return these packs are contacted for a more detailed neurodevelopmental, psychosocial, and growth assessment

8. 200 high-risk children (abnormal Dopplers and low growth trajectory)
Methodology
1116
200 high-risk children (abnormal Dopplers and low growth trajectory)
200 controls
(normal Dopplers)
All PORTO participants are contacted for initial follow-up with Ages and Stages Questionnaire
A subgroup of 400 are contacted for a detailed developmental assessment with the Bayley-III, CBCL, PedsQL, Beery-VMI, and anthropometric measures

9. Study Measures Ages and Stages Questionnaire, Third Edition (ASQ-3)
Parent-completed questionnaire assesses Communication, Fine Motor, Gross Motor, Social-Emotional, and Problem-Solving
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III):
A standardised, individually administered developmental assessment, consists of a series of developmental play tasks and measures Cognitive, Language, and Motor development
Child Behavior Checklist (CBCL):
Parent-completed questionnaire assesses maladaptive behavioural and emotional problems
Pediatric Quality of Life Inventory (PedsQL)
Parent-completed questionnaire assesses health-related quality of life, physical, emotional, social and school functioning
Beery-Buktenica Developmental Test of Visual-Motor Integration Short Form (Beery-VMI):
Drawings of geometric forms are presented in order of increasing difficulty and the child is asked to imitate or copy geometric designs

10. Recruitment to Date
Attempts have been made to contact 284 (25%) of the 1116 original PORTO participants to date in order to update contact details
180 (63%) of these 284 were successfully contacted by phone for updated contact details
All 284 have been sent invitation packs regardless of whether contact attempts were successful
100 of the 284 have returned ASQ-3 (35%), and 6 (2%) have voluntarily withdrawn or been removed due to T21 diagnosed postnatally
28 (28%) of these 100 have received detailed neurodevelopmental, psychosocial, and growth assessments to date

11. Recruitment to Date (n=284)

12. Next Steps Maintain current recruitment rate
Secure ethical approval in Northern Ireland for the PORTO participants who were recruited there
Recruitment of participants and neurodevelopmental, psychosocial, and growth assessments are scheduled to be completed by November 2015
Research findings are due to be disseminated by 2016

13. Strengths
This is the first follow-up study of a large national cohort of IUGR babies
The StOOPS study is a first-of-its-kind national study with fMRI analysis of growth-restricted infants. It will be interesting to see the long-term correlations of MRI findings with neurodevelopmental outcomes.
All the mothers recruited to StOOPS study have returned ASQ at 1 year
Potential for long-term follow up to assess
- School-age problems
- fMRI correlation with cognitive and behavioural problems
- Final adult height
- Risk of cardiovascular diseases, obesity, Type 2 diabetes, hypertension

14. Challenges Large proportion of non-nationals
Underscoring in Cognitive and Language areas of Bayley-III assessment
Face unique difficulties, e.g. no pronouns in certain European languages
Strict age cut-off of primary neurodevelopmental measure
Bayley-III testing valid till 42 months 15 days
Psychologists have to do other formal assessments beyond that age (WPSII, NEPSY etc.)

15. Recommendations Data collection at start of national trials
Contact details:
Suggest recording all available contact numbers
Annual update of home addresses and phone numbers
Get addresses
Infant characteristics:
Record head circumference at birth
Better documentation of a syndromic diagnosis prior to discharge from hospital, particularly if not admitted to NICU
Development of a central registry with birth, death, and medical records

16. Acknowledgements
Thanks to all the parents and children who have participated in the PORTO study and are continuing in the PANDA study follow-up, and to the sponsors of this stage of the study.