Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-26 @ 12:40 AM
Study NCT ID:
NCT02503020
Status:
COMPLETED
Last Update Posted:
2015-07-20
First Post:
2015-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arachidonic Acid Supplementation in Very Preterm Infants
Sponsor:
Health Research Institute of Santiago
Organization:
Study Overview
Official Title:
Effects of Different Arachidonic Acid Supplementation on Psychomotor Development in Very Preterm Infants, a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: