Effect of early fatty acid status on neurodevelopmental outcome at 9 years
| ISRCTN | ISRCTN52788665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52788665 |
| Protocol serial number | NTR364 |
| Sponsor | University Medical Centre Groningen (UMCG) (Netherlands) |
| Funder | Numico Research B.V. (Netherlands) |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 18/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof M Hadders-Algra
Scientific
Scientific
University Medical Center Groningen
Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | noemail@example.com |
|---|---|
| m.hadders-algra@med.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Neuromotor condition at 9 years |
| Key secondary outcome measure(s) |
Cognitive function at 9 years: |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2016 | 18/02/2021 | Yes | No |
Editorial Notes
18/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
