NCT02503020

Brief Summary

Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6), and docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of non-myelinated cell membranes in the central nervous system, including in the retina, hence the great importance of them for appropriate visual and cognitive development. In this study, the investigators assessed anthropometric, visual, auditory, and psychomotor development in very preterm infants who had diets supplemented with different LCPUFA amount of AA to support the importance of sufficient AA values in formula.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2011

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
Last Updated

July 20, 2015

Status Verified

July 1, 2015

Enrollment Period

3.3 years

First QC Date

July 14, 2015

Last Update Submit

July 17, 2015

Conditions

Impaired Psychomotor Development

Keywords

Arachidonic acidOmega-6/omega-3 ratioPreterm infants nutrition

Outcome Measures

Primary Outcomes (1)

  • Psychomotor development

    Evaluation of psychomotor development by making Brunet-Lezine scale at 2 years of corrected age.

    From september 2013 to november 2014 (at two years of corrected age)

Secondary Outcomes (5)

  • Levels of fatty acids in plasma

    From october 2011 to november 2013 (from 3 months to 1 years old)

  • Visual- and auditory-evoked potentials

    From january 2012 to February 2013 (from 6 months to 1 years old)

  • Weight

    From october 2011 to november 2014 (from 6 months to 2 years old)

  • Length

    From october 2011 to november 2014 (from 6 months to 2 years old)

  • Head circumference

    From october 2011 to november 2014 (from 6 months to 2 years old)

Study Arms (2)

Group A

ACTIVE COMPARATOR

Preterm infants formula A Pretarm infants were fed on formula with Arachidonic acid (0.6%) and Docosahexaenoic acid (0.3%)

Dietary Supplement: Preterm infants formula A

Group B

ACTIVE COMPARATOR

Preterm infants formula B Pretarm infants were fed on formula with Arachidonic acid (0.3%) and Docosahexaenoic acid (0.3%)

Dietary Supplement: Preterm infants formula B

Interventions

Preterm infants formula ADIETARY_SUPPLEMENT

Group A will receive a preterm infants formula supplemented with AA (0.6%) and DHA (0.3%) until they have three months corrected age. At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (2/1) until one year corrected age.

Group A
Preterm infants formula BDIETARY_SUPPLEMENT

Group B will receive other Preterm infants formula very similar, but with AA (0.3%) and DHA (0.3%) also until they have three months corrected age. At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (1/1) until one year corrected age.

Group B

Eligibility Criteria

Age1 Minute - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Living infants who were less than 1500 grams and/or less than 32 weeks gestational age, and whose parents accepted and subscribed the informed consent

You may not qualify if:

  • Preterm infants with any severe malformation.
  • Extremely preterm infants with a gestational age of less than 25 weeks.
  • Infants whose parents could not complete the follow-up process in our study center.
  • Preterm infants with severe intraventricular hemorrhage or periventricular leukomalacia (more than grade 2).
  • Neonates who did not need supplementary milk nutrition, i.e. breastfed-only children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alshweki A, Munuzuri AP, Bana AM, de Castro MJ, Andrade F, Aldamiz-Echevarria L, de Pipaon MS, Fraga JM, Couce ML. Effects of different arachidonic acid supplementation on psychomotor development in very preterm infants; a randomized controlled trial. Nutr J. 2015 Sep 30;14:101. doi: 10.1186/s12937-015-0091-3.

    PMID: 26424477DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 20, 2015

Study Start

July 1, 2011

Primary Completion

November 1, 2014

Study Completion

March 1, 2015

Last Updated

July 20, 2015

Record last verified: 2015-07