Arachidonic Acid Supplementation in Very Preterm Infants

NCT ID: NCT02503020

Last Updated: 2015-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-03-31

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.

Detailed Description

the investigators carried out a prospective randomized controlled double blinded trial in order to study nutritional supplements for preterm infants <1500 grams and/or <32 weeks gestational age (GA) who were born in clinical University Hospital of Santiago de Compostela (CHUS). They were enrolled for a period of 14 months (from July 2011 to August 2012) and followed up from birth until 2 years of age. Milk formulas were provided either as adjunct to insufficient amount of breast milk, or as full formula feeding. Breastfeeding was actively encouraged. Patients were randomized into one of the two formula groups, depending on the type of formula they were to receive. Group A's formula was supplemented with DHA (0.3% of all fatty acids) and AA (0.6%) with an ω-6/ω-3 ratio of 2/1. Group B's formula was supplemented with DHA (0.3%) and AA (0.3%) with an ω-6/ω-3 ratio of 1/1.

Primary outcome:

Assessment of psychomotor development with the Brunet Lézine scale at 2 years of age (Early Care Unit CHUS)

Secondary outcomes:

Physical examination and anthropometric measurements (weight, length, and head circumference) at birth and at 3, 6, 9, 12, 18, and 24 months of age (Neonatology Unit CHUS) Blood levels of fatty acids in the first week of life and at 3 months, 6 months, and 12 months. (Metabolic Unit. Hospital de Cruces, Bilbao) Visual- and auditory-evoked potentials at 6 and 12 months of age (Neurophysiology Unit CHUS)

Conditions

Impaired Psychomotor Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Preterm infants formula A

Intervention Type: DIETARY_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 B

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

Group Type: ACTIVE_COMPARATOR

Preterm infants formula B

Intervention Type: DIETARY_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.

Interventions

Preterm infants formula A

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.

Intervention Type: DIETARY_SUPPLEMENT

Preterm infants formula B

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Health Research Institute of Santiago

OTHER

Sponsor Role: lead

Responsible Party

Ayham alshweki

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 26424477 (View on PubMed)

Other Identifiers

Ayham

Identifier Type: -

Identifier Source: org_study_id