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The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are <28 weeks gestational age (GA) or <1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care plus placebo | Active Comparator | Infants will receive placebo (normal saline) in the first 28 days after birth. Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. |
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| Usual care plus vitamin D supplementation | Experimental | Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day. At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo is normal saline, given in the first 28 days after birth, prepared to have the same volume and appearance as vitamin D, which is a clear odorless solution. |
| Measure | Description | Time Frame |
|---|---|---|
| 25-hydroxyvitamin D (25[OH]D) level | about 28 days after birth | |
| Type of respiratory support required at 36 weeks postmenstrual age | Data will be reported categorically as:
| 36 weeks postmenstrual age (or at the time of discharge home if earlier) |
| Measure | Description | Time Frame |
|---|---|---|
| 25-hydroxyvitamin D (25[OH]D) level | 36 weeks after birth | |
| Length of Hospital stay | from time of birth to time of discharge (about 0 to 60 weeks after birth) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Jain, MD | The University of Texas Medical Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
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|
| 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth | Dietary Supplement | 800 IU/day Vitamin D supplementation until 400 IU/ day are provided as part of usual care. At that point the intervention becomes a supplement of 400 IU/day above that given with usual care. In this way all infants in the intervention group receive 800 IU/day of vitamin D total supplementation in the first 28 days after birth with feedings. |
|
|
| Usual Care | Other | Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices |
|
| Number of participants who are still on respiratory support |
Respiratory support includes supplemental oxygen and positive pressure ventilation. |
| 22 to 26 months corrected age |
| Number of days of supplemental oxygen | from time of birth to time of discharge (about 0 to 60 weeks after birth) |
| Number of days of mechanical ventilation | from time of birth to time of discharge (about 0 to 60 weeks after birth) |
| Number of days of positive pressure support | from time of birth to time of discharge (about 0 to 60 weeks after birth) |
| Number of participants who receive steroid treatment to decrease respiratory support | from baseline to 36 weeks postmenstrual age |
| Number of participants with pulmonary hypertension | 36 weeks postmenstrual age |
| Number of participants with wheezing | 2 years |
| Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator | Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome. | 28 days of life |
| Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator | Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome. | 36 weeks postmenstrual age |
| Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator | Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome. | 2 years |
| Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator | Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome. | 28 days of life |
| Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator | Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome. | 36 weeks postmenstrual age |
| Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator | Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome. | 2 years |
| Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator | Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome. | 28 days of life |
| Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator | Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome. | 36 weeks postmenstrual age |
| Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator | Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome. | 2 years |
| Number of participants with any fractures | from baseline to 36 weeks postmenstrual age |
| Number of participants with hospital-acquired sepsis | from day 3 after birth to the time of discharge (which is 0 to 60 weeks after birth) |
| Calcium level | 0 to 36 weeks postmenstrual age |
| Phosphorus level | 0 to 36 weeks postmenstrual age |
| Alkaline phosphatase level | 0 to 36 weeks postmenstrual age |
| Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Cognitive composite score) | Cognitive composite score ranges from 40 to 160, with a higher score indicating a better outcome. | 2 years |
| Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Language composite score) | Language composite score ranges from 40 to 160, with a higher score indicating a better outcome. | 2 years |
| Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Motor composite score) | Motor composite score ranges from 40 to 160, with a higher score indicating a better outcome. | 2 years |
| Number of participants with neurodevelopmental impairment (NDI) | 2 years |
| Number of participants who die or have a morbidity | Morbidities include retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), neurodevelopmental impairment (NDI), necrotizing enterocolitis (NEC), and patent ductus arteriosus (PDA). | 36 weeks postmenstrual age |
| Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) | about 28 days after birth |
| Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by LC-MS/MS | 36 weeks postmenstrual age |
| Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS | about 28 days after birth |
| Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS | 36 weeks postmenstrual age |
| Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS | about 28 days after birth |
| Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS | 36 weeks postmenstrual age |
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| 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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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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