Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001012460
Ethics application status
Approved
Date submitted
26/08/2025
Date registered
11/09/2025
Date last updated
11/09/2025
Date data sharing statement initially provided
11/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Association with brain size and developmental outcomes with Body composition in the moderate to late preterm infant.
Scientific title
Association with brain size and developmental outcomes with Body composition in the moderate to late preterm infant.
Secondary ID [1] 315236 0
The PremPod Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain growth 338695 0
Condition category
Condition code
Reproductive Health and Childbirth 334977 334977 0 0
Complications of newborn
Diet and Nutrition 334978 334978 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants are infants born moderate- to late-preterm (32+0–36+6 weeks) or with intrauterine growth restriction (<3rd centile or crossing greater than or equal to 2 growth centiles), compared with healthy term-born infants (39–41 weeks). The exposure of interest is preterm/IUGR birth and associated nutritional/growth factors, including, body composition IGF-1 levels.

What is involved for participants;
Growth and body composition assessments: weight, length, head circumference weekly until discharge; PeaPod body composition at term age and 3 months corrected. IGF-1 serum levels via blood test: 36–72 hours after birth, then weekly until discharge, Brain MRI at term corrected age (~40 weeks), Neurodevelopmental assessments: Prechtl’s General Movements and Hammersmith Infant Neurological Examination at 3–4 months corrected, Bayley-IV developmental assessment at 2 years corrected, Blood pressure at 2 years corrected.

Duration of observation; Participants are followed from birth until 2 years corrected age


Intervention code [1] 331849 0
Diagnosis / Prognosis
Comparator / control treatment
The control group will consist of healthy term-born infants, born between 39–41 weeks’ gestation, without intrauterine growth restriction or congenital abnormalities. These infants will undergo the same assessments as the preterm/IUGR groups (growth and body composition measurements, IGF-1 serum levels. MRI at term age, and neurodevelopmental follow-up to 2 years corrected age) to allow direct comparison with the study cohort.
Control group
Active

Outcomes
Primary outcome [1] 342609 0
Brain growth; These measures will be assessed as a composite primary outcome by comparison of bifrontal diameter (BFD), biparietal diameter (BPD), and transverse cerebellar diameter (TCD).
Timepoint [1] 342609 0
This will occur at term corrected gestation i.e 38-42 weeks corrected.
Secondary outcome [1] 451534 0
Developmental outcomes, General movements assessment (GMA), presence or absence of fidgety movements. (Measured as composite)
Timepoint [1] 451534 0
At 3 months corrected gestation
Secondary outcome [2] 451537 0
Developmental outcomes
Timepoint [2] 451537 0
2 years corrected gestation.

Eligibility
Key inclusion criteria
Babies born between 32+0 and 35+6 weeks’ gestation admitted to the neonatal unit or maternity ward. The control group will be healthy term infants born 39-41 weeks.
Minimum age
0 Days
Maximum age
3 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Neonates born with congenital abnormalities or metabolic conditions that are likely to affect growth, body composition or neurodevelopmental outcomes.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/11/2023
Date of last participant enrolment
Anticipated
1/08/2027
Actual
Date of last data collection
Anticipated
1/09/2029
Actual
Sample size
Target
110
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28388 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 44611 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 319803 0
University
Name [1] 319803 0
Monash University
Country [1] 319803 0
Australia
Primary sponsor type
Individual
Name
Dr David Mc Hugh, Monash University
Address
Country
Australia
Secondary sponsor category [1] 322317 0
Individual
Name [1] 322317 0
Prof Rod Hunt, Monash University
Address [1] 322317 0
Country [1] 322317 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318360 0
Monash Health Human Research Ethics Committee B
Ethics committee address [1] 318360 0
Ethics committee country [1] 318360 0
Australia
Date submitted for ethics approval [1] 318360 0
01/03/2023
Approval date [1] 318360 0
22/06/2023
Ethics approval number [1] 318360 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143938 0
Dr David Mc Hugh
Address 143938 0
Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168 Australia
Country 143938 0
Australia
Phone 143938 0
+61 48 584 3580
Fax 143938 0
Email 143938 0
[email protected]
Contact person for public queries
Name 143939 0
David Mc Hugh
Address 143939 0
Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168 Australia
Country 143939 0
Australia
Phone 143939 0
+61 48 584 3580
Fax 143939 0
Email 143939 0
[email protected]
Contact person for scientific queries
Name 143940 0
David Mc Hugh
Address 143940 0
Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168 Australia
Country 143940 0
Australia
Phone 143940 0
+61 48 584 3580
Fax 143940 0
Email 143940 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.