Arachidonic Acid Supplementation in Very Preterm Infants
Primary Purpose
Impaired Psychomotor Development
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Preterm infants formula A
Preterm infants formula B
Sponsored by

About this trial
This is an interventional screening trial for Impaired Psychomotor Development focused on measuring Arachidonic acid, Omega-6/omega-3 ratio, Preterm infants nutrition
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Preterm infants formula A Pretarm infants were fed on formula with Arachidonic acid (0.6%) and Docosahexaenoic acid (0.3%)
Preterm infants formula B Pretarm infants were fed on formula with Arachidonic acid (0.3%) and Docosahexaenoic acid (0.3%)
Outcomes
Primary Outcome Measures
Psychomotor development
Evaluation of psychomotor development by making Brunet-Lezine scale at 2 years of corrected age.
Secondary Outcome Measures
Levels of fatty acids in plasma
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
Visual- and auditory-evoked potentials were studied with special scale at 6 and 12 months of life
Weight
Weight at 3, 6, 9, 12, 18, and 24 months of life
Length
Length at 3, 6, 9, 12, 18, and 24 months of life
Head circumference
Head circumference at 3, 6, 9, 12, 18, and 24 months of life
Full Information
NCT ID
NCT02503020
First Posted
July 14, 2015
Last Updated
July 17, 2015
Sponsor
Health Research Institute of Santiago
1. Study Identification
Unique Protocol Identification Number
NCT02503020
Brief Title
Arachidonic Acid Supplementation in Very Preterm Infants
Official Title
Effects of Different Arachidonic Acid Supplementation on Psychomotor Development in Very Preterm Infants, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Research Institute of Santiago
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Psychomotor Development
Keywords
Arachidonic acid, Omega-6/omega-3 ratio, Preterm infants nutrition
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Preterm infants formula A Pretarm infants were fed on formula with Arachidonic acid (0.6%) and Docosahexaenoic acid (0.3%)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Preterm infants formula B Pretarm infants were fed on formula with Arachidonic acid (0.3%) and Docosahexaenoic acid (0.3%)
Intervention Type
Dietary Supplement
Intervention Name(s)
Preterm infants formula A
Intervention Description
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
Intervention Name(s)
Preterm infants formula B
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psychomotor development
Description
Evaluation of psychomotor development by making Brunet-Lezine scale at 2 years of corrected age.
Time Frame
From september 2013 to november 2014 (at two years of corrected age)
Secondary Outcome Measure Information:
Title
Levels of fatty acids in plasma
Description
Blood samples were obtained from study children to study the levels of fatty acids in plasma at 3 , 6 and 12 months of life
Time Frame
From october 2011 to november 2013 (from 3 months to 1 years old)
Title
Visual- and auditory-evoked potentials
Description
Visual- and auditory-evoked potentials were studied with special scale at 6 and 12 months of life
Time Frame
From january 2012 to February 2013 (from 6 months to 1 years old)
Title
Weight
Description
Weight at 3, 6, 9, 12, 18, and 24 months of life
Time Frame
From october 2011 to november 2014 (from 6 months to 2 years old)
Title
Length
Description
Length at 3, 6, 9, 12, 18, and 24 months of life
Time Frame
From october 2011 to november 2014 (from 6 months to 2 years old)
Title
Head circumference
Description
Head circumference at 3, 6, 9, 12, 18, and 24 months of life
Time Frame
From october 2011 to november 2014 (from 6 months to 2 years old)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
26424477
Citation
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.
Results Reference
derived
Learn more about this trial
Arachidonic Acid Supplementation in Very Preterm Infants
We'll reach out to this number within 24 hrs