Condition category
Mental and Behavioural Disorders
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
17/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof M Hadders-Algra

ORCID ID

Contact details

University Medical Center Groningen
Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands
m.hadders-algra@med.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR364

Study information

Scientific title

Acronym

LCP project

Study hypothesis

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

Received from local medical ethics committee

Study design

Randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2005

Overall trial end date

31/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy term infants

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

457

Participant 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

Recruitment start date

01/04/2005

Recruitment end date

31/03/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/azg/nl/english/azg/

Funders

Funder type

Industry

Funder name

Numico Research B.V. (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes