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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
Health Research Institute of Santiago
About
Eligibility
Locations
Arms
Outcomes
Full info

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

1 Minute - 2 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 14, 2015
    Last Updated
    July 17, 2015
    Sponsor
    Health Research Institute of Santiago
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    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

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    Arachidonic Acid Supplementation in Very Preterm Infants

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