Vitamin D Supplementation for Extremely Preterm Infants
2017年2月8日 更新者：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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
100
段階
- フェーズ2
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Alabama
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Birmingham、Alabama、アメリカ、35249
- University of Alabama at Birmingham
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
1分～1週間 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Oral Vitamin D--200 IU/day
Cholecalciferol 200 IU given orally once per day
|
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
他の名前：
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours.
Duration of 28 postnatal days
他の名前：
|
|
プラセボコンパレーター：Placebo
Identical-appearing treatment that does not contain the test drug given orally four times per day.
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Sterile water 0.5ml given orally every 6 hours.
Duration of 28 postnatal days
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アクティブコンパレータ：Oral Vitamin D--800 IU/day
Cholecalciferol 800 IU given orally once per day
|
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
他の名前：
800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours.
Duration of 28 postnatal days
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total number of days alive and off respiratory support in the first 28 days
時間枠：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
|
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Serum vitamin D concentration
時間枠：Day after birth 28
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Serum vitamin D levels determined by enzyme immunoassay obtained from whole blood (remnant sample or obtained during clinical blood draw)
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Day after birth 28
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of sepsis episodes treated with antibiotics for at least 5 days
時間枠：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
|
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Sepsis
時間枠：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
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
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Need for supplemental oxygen at 36 weeks of corrected age (Physiologic definition)
時間枠：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%.
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36 weeks gestational age corrected
|
|
Duration of mechanical ventilation after randomization
時間枠：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
|
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Days alive and off mechanical ventilation in the first 28 days after birth
時間枠：28 days
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Counted as days alive without mechanical ventilation for any part of a day
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28 days
|
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Number of re-intubation events
時間枠：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
時間枠：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
時間枠：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
|
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25(OH)D concentrations >60ng/ml (150 nmol/L)
時間枠：14 postnatal (+/- 2 days)
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Vitamin D measurement per blood obtained either centrally or by heel stick.
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14 postnatal (+/- 2 days)
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25(OH)D concentrations >60ng/ml (150 nmol/L)
時間枠：28 days postnatal age (+/- 3 days)
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Vitamin D measurement per blood obtained either centrally or by heel stick.
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28 days postnatal age (+/- 3 days)
|
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Serum calcium level
時間枠：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
|
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Urine calcium level
時間枠：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.
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Participants will be followed for the duration of hospital stay, an expected average of 4 months
|
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Meningitis
時間枠：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
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Death or Neurodevelopmental Impairment
時間枠：Birth to 22-26 months of age
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Birth to 22-26 months of age
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Ariel A. Salas, MD、University of Alabama at Birmingham
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
- Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年6月1日
一次修了 (実際)
2014年12月1日
研究の完了 (実際)
2016年12月1日
試験登録日
最初に提出
2012年5月14日
QC基準を満たした最初の提出物
2012年5月15日
最初の投稿 (見積もり)
2012年5月17日
学習記録の更新
投稿された最後の更新 (実際)
2017年2月10日
QC基準を満たした最後の更新が送信されました
2017年2月8日
最終確認日
2017年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。