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Vitamin D Supplementation for Extremely Preterm Infants

8. februar 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35249
        • University of Alabama at Birmingham

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 minut til 1 uge (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Oral Vitamin D--200 IU/day
Cholecalciferol 200 IU given orally once per day
Kosttilskud: 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 navne:
  • D-vitamin
Kosttilskud: 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 navne:
  • D-vitamin
Placebo komparator: Placebo
Identical-appearing treatment that does not contain the test drug given orally four times per day.
Kosttilskud: 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
Kosttilskud: 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 navne:
  • D-vitamin
Kosttilskud: 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 navne:
  • D-vitamin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Alabama at Birmingham

Samarbejdspartnere

Children's Health System, Alabama

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

14. maj 2012

Først indsendt, der opfyldte QC-kriterier

15. maj 2012

Først opslået (Skøn)

17. maj 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UAB Neo 006

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med D-vitamin mangel

Kliniske forsøg med Cholecalciferol

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