Enteral High-dose DHA Supplementation on Bronchopulmonary Dysplasia in Very Preterm Infants: a Collaborative Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1801 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2026-03-31

Brief Summary

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This one-stage individual participant data (IPD) meta-analysis study will aim to determine whether high-dose docosahexaenoic acid (DHA) enteral supplementation during the neonatal period is associated with the risk for severe bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age (PMA) compared to control, in contemporary cohorts of preterm infants born at less than 29 weeks of gestation. The association between high-dose DHA and severe BPD will also be explored in important subgroups according to sex, gestational age, small-for-gestational age and mode of delivery.

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Detailed Description

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Severe BPD is a well-known factor consistently associated with impaired cognitive outcomes. Regarding reported benefits on long-term neurodevelopmental outcomes, the potential adverse effects of high-dose DHA supplementation on this short-term neonatal morbidity needs further investigations in infants born very preterm.

Therefore, based on previous systematic review findings and a known association between more severe BPD and unfavorable neurodevelopmental outcomes, a deeper understanding of the association between DHA and severe BPD needs further investigations. Harmonization of the severe BPD definition across the recent DHA trials, reclassified according to modern criteria will strengthen the results and allow their interpretation in balance with the potential efficacy of DHA on long-term neurodevelopmental outcomes. Moreover, inconsistent differential responses of DHA on BPD were previously reported according to subgroups such as sex, gestational age and mode of delivery and need to be further explored in this more vulnerable population.

Conditions

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Bronchopulmonary Dysplasia Child Development Neonatal and Perinatal Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The prior systematic review included a meta-analysis of aggregated data of trials that examined the effects of an enteral supplementation with high-dose DHA during the neonatal period on the risk for BPD (any definition), death, BPD severity (any definition) and a combined outcome of BPD or death in preterm infants born less than 29 weeks of gestation. Information on data sources (searched up to August 1st, 2022), search strategy, selection process, data extraction and risk of bias assessment were detailed in the prior protocol and publication. All four trials included in the prior systematic review will be considered for inclusion in this IPD meta-analysis.

Upon the early period of selecting studies for the prior systematic review, the principal investigator (IM) has contacted the primary author of trials for potential agreement to share de-identified IPD for the purpose of this participant-level meta-analysis. All IPD datasets will be harmonised and combined into one large dataset.

Study Groups

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High-dose DHA

Enteral supplementation with high-dose DHA in the neonatal period.

Group Type EXPERIMENTAL

High-dose DHA

Intervention Type DIETARY_SUPPLEMENT

Direct enteral DHA supplementation at a dose of at least 40 mg/kg/day or DHA supplementation of breast milk or formula aiming for at least 0.4% of total fatty acids.

Control

Control.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Control with no or low-dose DHA.

Interventions

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High-dose DHA

Direct enteral DHA supplementation at a dose of at least 40 mg/kg/day or DHA supplementation of breast milk or formula aiming for at least 0.4% of total fatty acids.

Intervention Type DIETARY_SUPPLEMENT

Control

Control with no or low-dose DHA.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

The intervention has to involve enteral administration of high-dose DHA supplementation during the neonatal period. A high-dose DHA supplementation is defined as direct enteral DHA supplementation at a dose of at least 40 mg/kg/day or DHA supplementation of breast milk or formula aiming for at least 0.4% of total fatty acids. The intervention should be randomly assigned as either enteral administration of high-dose DHA supplementation OR a control with no or low-dose DHA.

Trials evaluating intravenous DHA interventions or combined interventions (e.g. DHA combined to other nutrients or long-chain polyunsaturated fatty acids) are not considered for inclusion in this IPD meta-analysis to isolate the DHA effects and avoid heterogeneity in the intervention.

The IPD meta-analysis will be conducted using a harmonized severity-based definition of BPD in eligible trials. This definition will be based on Jensen's criteria that adequately predict childhood outcomes in a contemporary cohort of infants born very preterm. To be included, prospectively collected data from eligible trials should allow BPD severity outcome classification and harmonization according to Jensen's severity-based BPD criteria at 36 weeks' PMA.

Maximum Eligible Age

14 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes