Effect of early fatty acid status on neurodevelopmental outcome at 9 years

ISRCTN	ISRCTN52788665
DOI	https://doi.org/10.1186/ISRCTN52788665
Secondary identifying numbers	NTR364

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof M Hadders-Algra
Scientific

University Medical Center Groningen
Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	noemail@example.com
Email	m.hadders-algra@med.umcg.nl

Study design	Randomised open label active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title	Effect of early fatty acid status on neurodevelopmental outcome at 9 years
Study acronym	LCP project
Study objectives	1. Postnatal supplementation of infant formula with long-chain polyunsaturated fatty acids (LCPUFA) improves neurodevelopmental outcome at 9 years in healthy full-term infants 2. Neonatal fatty acid status affects neurodevelopmental outcome at 9 years in healthy full-term infants
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Developmental disorder
Intervention	Three groups: 1. Control formula (CF) group (n = 162), 2. LCPUFA-supplemented formula (LF) group (n = 139) 3. Breast-fed (BF) group (n = 156). LCPUFA-supplemented formula (LF) group: standard infant formula enriched with 0.45% arachidonic acid (AA) and 0.30% docosahexaenoic acid (DHA).
Intervention type	Other
Primary outcome measure	Neuromotor condition at 9 years
Secondary outcome measures	Cognitive function at 9 years: 1. Attention and executive functions 2. Language 3. Memory and learning 4. Behavioural problems
Overall study start date	01/04/2005
Completion date	31/03/2010

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	457
Total final enrolment	229
Key inclusion criteria	Healthy term infants
Key exclusion criteria	1. A congenital disorder interfering with adequate functioning in daily life 2. Children from multiple births 3. Children whose mother did not master the Dutch language or suffered from significant illness or disability 4. Adopted and fostered children 5. Formula-fed infants who had received human milk for more than 5 days
Date of first enrolment	01/04/2005
Date of final enrolment	31/03/2010

University Medical Center Groningen

Groningen
9700 RB
Netherlands

University Medical Centre Groningen (UMCG) (Netherlands)
Hospital/treatment centre

Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands

Website	http://www.umcg.nl/azg/nl/english/azg/
"ROR"	https://ror.org/03cv38k47

Industry

Numico Research B.V. (Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2016	18/02/2021	Yes	No

18/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.