Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-72
SponsorUniversity of Alabama at Birmingham

About this trial

Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Gestational ages between 22 0/7 - 32 6/7 weeks gestation

< 25th centile birthweight

Disqualifiers

Major congenital/chromosomal anomalies

Terminal illness in which decisions to withhold or limit support have been made

Trial design

Design model

Parallel

Treatments tested in this trial

  • DHA

    Dietary supplement

    DHA supplementation

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Head circumference at 36 weeks postmenstrual age or discharge

Declines in head circumference z scores from birth to 36 weeks postmenstrual age

Time frame
Birth to 36 weeks postmenstrual age or discharge

Secondary outcomes

1

Fat mass(FM)-for-age Z-score

FM accretion will be estimated by air displacement plethysmography

Time frame
Birth to 36 weeks postmenstrual age
2

Changes in serum metabolic profile at 36 weeks postmenstrual age

Determined by metabolomic analyses of serum samples

Time frame
36 weeks postmenstrual age or discharge

Other outcomes

1

Cognitive outcomes

Determined by Bayley assessment

Time frame
2 years of age

Sponsors and contacts

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University of Alabama at Birmingham

Lead sponsor

Mead Johnson Nutrition

Collaborator