Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants (SAFE)
調査の概要
状態
条件
詳細な説明
Very preterm infants (born <32 weeks gestational age) are at high risk for postnatal growth faltering, which is associated with adverse neurodevelopmental outcomes. Despite routine use of enriched human milk fortification in the NICU, many infants fail to achieve adequate somatic and lean mass growth. Sodium depletion has been identified as a potentially modifiable contributor to this problem: renal tubular immaturity in preterm infants results in obligate urinary sodium wasting. Total body sodium depletion has been associated with poor growth in infants and poor muscle mass development in animal studies.
Current NICU practice relies primarily on serum sodium to guide supplementation; however, serum sodium is a late and insensitive marker of total body sodium depletion. Urine sodium is a more sensitive indicator of sodium balance and may identify depletion before serum levels fall. Gestational-age-specific urine sodium thresholds to guide supplementation have recently been proposed (Stalter et al., 2025), but have evaluated body composition in a prospective randomized trial.
This trial tests whether a structured, urine sodium-guided supplementation protocol based on every other week urine and serum sodium monitoring improves anthropometric growth and lean mass accrual compared to standard enriched fortification alone. The intervention runs from day of life 14 through 36 weeks postmenstrual age, with tapering through 38 weeks PMA.
Body composition assessment incorporates two complementary modalities: serial point-of-care ultrasound (POCUS) of the biceps, rectus femoris, and subcutaneous fat for longitudinal lean and fat mass tracking, and Air Displacement Plethysmography (PeaPod) at 36 weeks postmenstrual age or discharge for criterion-standard whole-body composition. Fat mass, fat-free mass, and body fat percentage will be referenced against the Norris et al. preterm normative curves.
The trial uses an open-label design with block randomization stratified by gestational age. A Data Safety and Monitoring Board will conduct oversight and interim safety reviews.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Debbie Ng, MPH
- メール：ngdm@uw.edu
研究連絡先のバックアップ
- 名前：John Feltner, MS
- 電話番号：(206) 543-3200
- メール：jfeltner@uw.edu
研究場所
-
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Ohio
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Cincinnati、Ohio、アメリカ、45221
- まだ募集していません
- University of Cincinnati
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コンタクト：
- Ting Ting Fu, MD
- 電話番号：513-636-4200
- メール：futn@ucmail.uc.edu
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Oregon
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Portland、Oregon、アメリカ、97239
- まだ募集していません
- Oregon Health & Science University
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コンタクト：
- Brian Scottoline, MD, PhD
- 電話番号：(503) 494-8122
- メール：scottoli@ohsu.edu
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Washington
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Seattle、Washington、アメリカ、98195
- 募集
- University of Washington
-
コンタクト：
- Katie M Strobel, MD, MSCR
- 電話番号：(206) 543-3200
- メール：kmstrob@uw.edu
-
副調査官：
- D Taylor Hendrixson, MD, MPH
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Admitted to the University of Washington, Oregon Health and Sciences, or University of Cincinnati NICU at 14 days of age
- Born between 24w0days and 31w6d
- Achieved full enteral feeding
Exclusion Criteria:
- Congenital or chromosomal anomalies affecting growth
- Acute renal insufficiency (KDIGO stage 1 or higher)
- Necrotizing enterocolitis (modified Bell's stage IIA or higher)
- Anticipated NICU stay less than 30 days
- Enrollment in a concurrent interventional study that may confound study outcomes
研究計画
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Targeted sodium supplementation
Every two weeks serum sodium and urine sodium testing with sodium supplementation if indicated by algorithm.
Milk fortification per growth metrics.
|
The investigators will utilize urine sodium testing every two weeks in conjunction with serum sodium testing to determine if sodium supplementation is indicated.
The investigators will use serum sodium testing to determine if sodium supplementation or adjustments to sodium supplementation need to be made.
The investigators will provide milk fortification using either a bovine-based or a human-milk-based fortifier (per unit protocol), based on growth trajectories.
|
|
アクティブコンパレータ：Enriched Milk Fortification
Serum sodium testing every two weeks with sodium supplementation if indicated by clinical team.
Milk fortification per growth metrics.
|
The investigators will use serum sodium testing to determine if sodium supplementation or adjustments to sodium supplementation need to be made.
The investigators will provide milk fortification using either a bovine-based or a human-milk-based fortifier (per unit protocol), based on growth trajectories.
|
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 |
|---|---|---|
|
Body composition by point-of-care ultrasound
時間枠：Enrollment to study completion, on average 4-10 weeks
|
Evaluate muscle and subcutaneous fat accretion from enrollment to 36 weeks posmtnestrual age.
The study team will perform biceps and rectus femoris cross-sectional area measurements using point-of-care ultrasound every 2 weeks.
We will perform arm and mid-thigh subcutaneous fat measurements using point-of-care ultrasound every 2 weeks.
|
Enrollment to study completion, on average 4-10 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body composition using air-displacement plethysmography
時間枠：At study completion, on average 4-10 weeks
|
We will conduct air-displacement plethysmography when the infant is off of oxygen at 36 weeks postmenstrual age or prior to discharge, whichever comes earlier.
|
At study completion, on average 4-10 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Anthropometric growth
時間枠：Enrollment to study completion, on average 4-10 weeks
|
The clinical team measures weight, length, and head circumference z-scores weekly during hospitalization.
The investigators will evaluate the change in z-score from birth to 36 weeks postmenstrual age
|
Enrollment to study completion, on average 4-10 weeks
|
|
Adverse outcomes
時間枠：Enrollment to hospital discharge, on average between 4 to 16 weeks
|
The study team will evaluate adverse outcome rates such as bronchopulmonary dysplasia, necrotizing enterocolitis, and all-cause mortality.
|
Enrollment to hospital discharge, on average between 4 to 16 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Katie Strobel, MD, MSCR、University of Washington
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- STUDY00023657
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有サポート情報タイプ
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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