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| ID | Type | Description | Link |
|---|---|---|---|
| 8726 | Other Grant/Funding Number | Mead Johnson Nutrition |
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| Name | Class |
|---|---|
| Mead Johnson Nutrition | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | A DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth. |
|
| Control | No Intervention | No DHA/ARA supplement will be added to expressed human milk or donor human milk administered during the first 3 weeks after birth. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHA | Dietary Supplement | DHA supplementation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Head circumference at 36 weeks postmenstrual age or discharge | Declines in head circumference z scores from birth to 36 weeks postmenstrual age | Birth to 36 weeks postmenstrual age or discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Fat mass(FM)-for-age Z-score | FM accretion will be estimated by air displacement plethysmography | Birth to 36 weeks postmenstrual age |
| Changes in serum metabolic profile at 36 weeks postmenstrual age |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive outcomes | Determined by Bayley assessment | 2 years of age |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ariel A Salas, MD, MSPH | Contact | 205-934-4680 | asalas@uab.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D007228 | Infant Nutrition Disorders |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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Determined by metabolomic analyses of serum samples
| 36 weeks postmenstrual age or discharge |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |