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Vitamin D Supplementation for Extremely Preterm Infants

8. februar 2017 oppdatert av: Namasivayam Ambalavanan, University of Alabama at Birmingham

Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial

The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

After informed consent obtained, infants will be randomized using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to one of the treatment arms or to a placebo concurrent control.

Early vitamin D supplementation/placebo will be initiated within the first 7 days after birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D: either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. After this period of supplementation, routine supplementation will be conducted in all groups.

Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D [25(OH)D]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found.

Supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations >60ng/mL (>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If infant made briefly NPO (<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D will not be discontinued.

All infants will be followed to discharge for primary, secondary outcomes as well as adverse events.

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35249
        • University of Alabama at Birmingham

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 minutt til 1 uke (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks

Exclusion Criteria:

  • Major congenital/chromosomal anomalies
  • Moribund infant with low likelihood of survival, in opinion of the clinical team

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Oral Vitamin D--200 IU/day
Cholecalciferol 200 IU given orally once per day
Kosttilskudd: Cholecalciferol
200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours. Other 3 doses will be placebo (sterile water). Duration of 28 postnatal days
Andre navn:
  • Vitamin d
Kosttilskudd: Cholecalciferol
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours. Duration of 28 postnatal days
Andre navn:
  • Vitamin d
Placebo komparator: Placebo
Identical-appearing treatment that does not contain the test drug given orally four times per day.
Kosttilskudd: Placebo
Sterile water 0.5ml given orally every 6 hours. Duration of 28 postnatal days
Aktiv komparator: Oral Vitamin D--800 IU/day
Cholecalciferol 800 IU given orally once per day
Kosttilskudd: Cholecalciferol
200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours. Other 3 doses will be placebo (sterile water). Duration of 28 postnatal days
Andre navn:
  • Vitamin d
Kosttilskudd: Cholecalciferol
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours. Duration of 28 postnatal days
Andre navn:
  • Vitamin d

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total number of days alive and off respiratory support in the first 28 days
Tidsramme: 28 days
The total number of days alive and off respiratory support. Respiratory support is defined as need of supplemental oxygen and/or positive pressure ventilation to maintain normal target oxygen saturations (88-95%).
28 days
Serum vitamin D concentration
Tidsramme: Day after birth 28
Serum vitamin D levels determined by enzyme immunoassay obtained from whole blood (remnant sample or obtained during clinical blood draw)
Day after birth 28

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of sepsis episodes treated with antibiotics for at least 5 days
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 4 months
Number of episodes of culture proven or clinically suspected sepsis episodes treated with antibiotics for at least 5 days
Participants will be followed for the duration of hospital stay, an expected average of 4 months
Sepsis
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 4 months
Culture proven or culture negative clinically treated course consistent with sepsis
Participants will be followed for the duration of hospital stay, an expected average of 4 months
Need for supplemental oxygen at 36 weeks of corrected age (Physiologic definition)
Tidsramme: 36 weeks gestational age corrected
A physiologic oxygen challenge test will be administered to infants from 36.0 weeks gestation to 37.0 weeks gestation to determine a need for supplemental oxygen to keep saturation levels between 88-95%.
36 weeks gestational age corrected
Duration of mechanical ventilation after randomization
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 4 months
Counted as number of days on which an infant is on mechanical ventilation for any part of a calendar day
Participants will be followed for the duration of hospital stay, an expected average of 4 months
Days alive and off mechanical ventilation in the first 28 days after birth
Tidsramme: 28 days
Counted as days alive without mechanical ventilation for any part of a day
28 days
Number of re-intubation events
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 4 months
Counted as number of reintubations for purposes of respiratory support
Participants will be followed for the duration of hospital stay, an expected average of 4 months
Death
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 4 months
Cardiorespiratory failure
Participants will be followed for the duration of hospital stay, an expected average of 4 months
Surgical necrotizing enterocolitis or intestinal perforation
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 4 months
Radiographic documentation of pneumatosis or intestinal perforation or treatment course for clinical necrotizing enterocolitis per Bell's stage greater than 1.
Participants will be followed for the duration of hospital stay, an expected average of 4 months
25(OH)D concentrations >60ng/ml (150 nmol/L)
Tidsramme: 14 postnatal (+/- 2 days)
Vitamin D measurement per blood obtained either centrally or by heel stick.
14 postnatal (+/- 2 days)
25(OH)D concentrations >60ng/ml (150 nmol/L)
Tidsramme: 28 days postnatal age (+/- 3 days)
Vitamin D measurement per blood obtained either centrally or by heel stick.
28 days postnatal age (+/- 3 days)
Serum calcium level
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 4 months
Serum calcium measurement per blood obtained either centrally or by heel stick, performed for clinical care. High serum calcium level is greater than 3 mmol/l of total calcium or total calcium of >12 mg/dL, or ionized calcium >2 mml/L.
Participants will be followed for the duration of hospital stay, an expected average of 4 months
Urine calcium level
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 4 months
Calcium measurement per urine, random sampling. High level (>95%tile) urine calcium to creatinine ratio is >3.8 mmol/mmol.
Participants will be followed for the duration of hospital stay, an expected average of 4 months
Meningitis
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 4 months
Culture proven or culture negative clinically treated course consistent with meningitis
Participants will be followed for the duration of hospital stay, an expected average of 4 months

Andre resultatmål

Resultatmål
Tidsramme
Death or Neurodevelopmental Impairment
Tidsramme: Birth to 22-26 months of age
Birth to 22-26 months of age

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Alabama at Birmingham

Samarbeidspartnere

Children's Health System, Alabama

Etterforskere

  • Studieleder: Ariel A. Salas, MD, University of Alabama at Birmingham

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2012

Primær fullføring (Faktiske)

1. desember 2014

Studiet fullført (Faktiske)

1. desember 2016

Datoer for studieregistrering

Først innsendt

14. mai 2012

Først innsendt som oppfylte QC-kriteriene

15. mai 2012

Først lagt ut (Anslag)

17. mai 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UAB Neo 006

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