Trajectories of Healthy Recovery in Infants: Evaluating Growth and Development after Critical Illness, in the Sophia Children*s Hospital

Trajectories of Healthy Recovery in Infants: Evaluating Growth and Development after Critical Illness, in the Sophia Children*s Hospital - THRIVE-S

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57631

Enrollment

104

Registered

2025-01-24

Start date

2025-11-10

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Critical Illness

Interventions

None listed

Eligibility

Age

No minimum to 11 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: - Term (>=37wks GA) newborn admitted 48 hours. AND: - Will have major cardiac procedure*

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded  from participation in this study: - Confirmed or suspected syndromes known to affect neurodevelopment  significantly - Perinatal asphyxia (cord blood pH or, if absent, first postnatal pH < 7.0 and  APGAR score at 5 min below 5) - Expected death within 24 hours after admission to intensive care unit or  fatal neuro-logical prognosis - Antenatally planned long term follow-up in another 3rd line medical centre  (this will be the case for some CHD neonates from region Nijmegen) - Parental language barriers that cannot be overcome with standard  translational ser-vices used for care in the Erasmus MC Sophia Children*s  Hospital.

Design outcomes

Primary

Measure	Time frame
Cognitive (overall) scores at two, five and eight years of age. These are measured through testing of (motor) development and cognition: Bayley Scales of Infant and Toddler Development (BSID-III) at two years, Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV-NL,) at five years and Wechsler Intelligence Scale for Children (WISC-V-NL) at eight years of age. These are continuous outcomes; scores are calculated with reference values on age-of-testing and sex. Mean scores of 100 are considered average for the population. Body composition and growth parameters. Among which are: Fat Free mass (kg), FFM index, weight-for-age (z-score, Fenton or WHO reference charts), height-for-age (z-score), head circumference (z-score) etc. Anthropometry at all follow-up moments (including virtual visit at 3 months), and body composition during hospital admission at six months, and two, five and eight years of age.	—

Measure

Time frame

Cognitive (overall) scores at two, five and eight years of age. These are measured through testing of (motor) development and cognition: Bayley Scales of Infant and Toddler Development (BSID-III) at two years, Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV-NL,) at five years and Wechsler Intelligence Scale for Children (WISC-V-NL) at eight years of age. These are continuous outcomes; scores are calculated with reference values on age-of-testing and sex. Mean scores of 100 are considered average for the population. Body composition and growth parameters. Among which are: Fat Free mass (kg), FFM index, weight-for-age (z-score, Fenton or WHO reference charts), height-for-age (z-score), head circumference (z-score) etc. Anthropometry at all follow-up moments (including virtual visit at 3 months), and body composition during hospital admission at six months, and two, five and eight years of age.

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Secondary

Measure	Time frame
The parameters can be classified in two groups: Exposures (mostly during admission) • Clinical factors and possible confounders such as pregestational maternal BMI, preg-nancy parameters, gestational age ay birth, birth characteristics; type of ICU admis-sion, surgical and anesthesiologic parameters; ICU mortality scores, ventilation days, inotropics use; • In-hospital growth in anthropometrics and body composition around discharge • Nutritional intake during hospitalisation, including both enteral and parenteral macro- and micronutrients, type of feeds, fortifiers, nutritional problems, indicators or feeding intolerance; • Nutritional intake post discharge: amounts and type of nutrition at index moments, duration of mothers milk feeding, alternative routes (tube), additional supplements and fortifiers, nutritional policy changes after discharge, indictors or feeding intolerance; • Alterations and potential injury on brain MRI during admission, see MRI outcomes; • Serum biomarkers for disease severity (lactate, CRP etc: routine care) and early brain damage correlates (NSE, GFAP, NfL: research) three times around hit*, e.g. at admission or around major procedure and in stable phase; • Self-regulation observations during admission both during ICU admission, and if possible after ICU but during hospital admission on the general wards. • Socio-economic position indicators: parental highest completed education, current occupation, income and residential zip-code. Outcomes (mostly after discharge) 1. Body composition (FM, FFM index etc) and conventional growth parameters (weight-for-age, height-for-age etc.) at five time points (six months; one, two, five and eight years of age). 2. Cognitive and behavioral outcomes at two, five and eight years measured through testing of development and cognition (BSID-III WPPSI, WISC) 3. Neurological imaging alterations (qualitative markers of brain injury [Kidokoro score] [Kikodoro 2013]and quantitative measures of brain structure	—

Measure

Time frame

The parameters can be classified in two groups: Exposures (mostly during admission) • Clinical factors and possible confounders such as pregestational maternal BMI, preg-nancy parameters, gestational age ay birth, birth characteristics; type of ICU admis-sion, surgical and anesthesiologic parameters; ICU mortality scores, ventilation days, inotropics use; • In-hospital growth in anthropometrics and body composition around discharge • Nutritional intake during hospitalisation, including both enteral and parenteral macro- and micronutrients, type of feeds, fortifiers, nutritional problems, indicators or feeding intolerance; • Nutritional intake post discharge: amounts and type of nutrition at index moments, duration of mother*s milk feeding, alternative routes (tube), additional supplements and fortifiers, nutritional policy changes after discharge, indictors or feeding intolerance; • Alterations and potential injury on brain MRI during admission, see *MRI outcomes*; • Serum biomarkers for disease severity (lactate, CRP etc: routine care) and early brain damage correlates (NSE, GFAP, NfL: research) three times around *hit*, e.g. at admission or around major procedure and in stable phase; • Self-regulation observations during admission both during ICU admission, and if possible after ICU but during hospital admission on the general wards. • Socio-economic position indicators: parental highest completed education, current occupation, income and residential zip-code. Outcomes (mostly after discharge) 1. Body composition (FM, FFM index etc) and conventional growth parameters (weight-for-age, height-for-age etc.) at five time points (six months; one, two, five and eight years of age). 2. Cognitive and behavioral outcomes at two, five and eight years measured through testing of development and cognition (BSID-III WPPSI, WISC) 3. Neurological imaging alterations (qualitative markers of brain injury [Kidokoro score] [Kikodoro 2013]and quantitative measures of brain structure

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Countries

Netherlands

Contacts

Public ContactG. Hasperhoven

Erasmus MC, Universitair Medisch Centrum Rotterdam

g.hasperhoven@erasmusmc.nl010-7037029

Outcome results