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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL183268 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-energy Group | Active Comparator | The intervention group receives a standard fortified human milk (maternal or donor) diet plus the DHA/ARA supplement for the first 14 days. Infants in this group will be secondarily assigned to either a low-dose (60/120 mg/kg/day) or high-dose (120/240 mg/kg/day) DHA/ARA supplement. |
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| Standard-energy Group | Other | The control group receives a standard fortified human milk (maternal or donor) diet for the first 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-energy group | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of respiratory morbidity | 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. | 0 - 120 days |
| Non-invasive impulse oscillometry measurements of pulmonary mechanics | Using the N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX) | 40 - 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchopulmonary dysplasia | Defined as the need for ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age | 40 - 120 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ariel A. Salas, MD, MSPH | Contact | 205-934-4680 | asalas@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ariel A. Salas, MD, MSPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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Following written informed consent, participants are assigned in a 2:1 ratio to either the intervention (supplementation) or control (standard diet) group.
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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.
| Standard-energy group | Other | Study participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth. |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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