Bronchopulmonary Dysplasia, Enteral Nutrition, Extreme Prematurity
Conditions
Keywords
Prematurity; Extreme
Brief summary
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung function in extremely preterm (EPT) infants (born at ≤28 weeks gestation).
Detailed description
This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a docosahexaenoic acid/arachidonic acid (DHA/ARA)-enriched, fortified human milk diet (intervention group) or a standard fortified human milk diet (control group) during the first 14 days after birth.
Interventions
DIETARY_SUPPLEMENTHigh-energy group
Study participants assigned to the intervention group will receive a standard, fortified human milk diet plus a DHA/ARA supplement during the first 2 weeks after birth.
OTHERStandard-energy group
Study participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth.
Sponsors
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
To maintain trial integrity, nutrition room staff that are independent of clinical care will prepare the feeding syringes without DHA/ARA labels to ensure clinicians, parents, and evaluators remain masked.
Intervention model description
Following written informed consent, participants are assigned in a 2:1 ratio to either the intervention (supplementation) or control (standard diet) group.
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Days
Healthy volunteers
No
Inclusion criteria
* Gestational age ≤ 28 weeks of gestation * Postnatal age \< 72 hours
Exclusion criteria
* Congenital malformations * Chromosomal anomalies * Terminal illness needing to limit or withhold support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of respiratory morbidity | 0 - 120 days | A scoring system that defines severity of respiratory morbidity (bronchopulmonary dysplasia severity) based on the amount of ventilatory support and the need for supplemental oxygen at 36 weeks postmenstrual age using the Jensen criteria, an ordinal scale ranging from 0 (no respiratory support) to 1 (mild BPD: low-flow nasal cannula ≤2 L/min requirement); 2 (moderate BPD: non-invasive respiratory support, including high-flow nasal cannula \>2 L/min, CPAP, or non-invasive positive pressure ventilation); 3 (severe BPD - invasive mechanical ventilation); or 4 (death), with progressively higher scores indicating increasing respiratory morbidity and worse clinical outcomes. |
| Non-invasive impulse oscillometry measurements of pulmonary mechanics | 40 - 120 days | Using the N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bronchopulmonary dysplasia | 40 - 120 days | Defined as the need for ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age |
Countries
United States
Contacts
CONTACTAriel A. Salas, MD, MSPH
PRINCIPAL_INVESTIGATORAriel A. Salas, MD, MSPH
University of Alabama at Birmingham
Outcome results
None listed