Arachidonic Acid Supplementation in Very Preterm Infants

Phase 2

Completed

• Conditions: Impaired Psychomotor Development
• Interventions: Dietary Supplement: Preterm infants formula B; Dietary Supplement: Preterm infants formula A

• Registration Number: NCT02503020
• Lead Sponsor: Health Research Institute of Santiago

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)

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2014-11
• Study Completion: 2015-03
• Status Verified: 2015-07
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-17
• Last Update Submitted: 2015-07-17
• Study First Posted: 2015-07-20
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Psychomotor development	From september 2013 to november 2014 (at two years of corrected age)	Evaluation of psychomotor development by making Brunet-Lezine scale at 2 years of corrected age.

Secondary Outcome Measures

Name	Time	Method
Length	From october 2011 to november 2014 (from 6 months to 2 years old)	Length at 3, 6, 9, 12, 18, and 24 months of life
Head circumference	From october 2011 to november 2014 (from 6 months to 2 years old)	Head circumference at 3, 6, 9, 12, 18, and 24 months of life
Levels of fatty acids in plasma	From october 2011 to november 2013 (from 3 months to 1 years old)	Blood samples were obtained from study children to study the levels of fatty acids in plasma at 3 , 6 and 12 months of life
Visual- and auditory-evoked potentials	From january 2012 to February 2013 (from 6 months to 1 years old)	Visual- and auditory-evoked potentials were studied with special scale at 6 and 12 months of life
Weight	From october 2011 to november 2014 (from 6 months to 2 years old)	Weight at 3, 6, 9, 12, 18, and 24 months of life