Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants (SAFE)
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Debbie Ng, MPH
- 이메일: ngdm@uw.edu
연구 연락처 백업
- 이름: John Feltner, MS
- 전화번호: (206) 543-3200
- 이메일: jfeltner@uw.edu
연구 장소
-
-
Ohio
-
Cincinnati, Ohio, 미국, 45221
- 아직 모집하지 않음
- University of Cincinnati
-
연락하다:
- Ting Ting Fu, MD
- 전화번호: 513-636-4200
- 이메일: futn@ucmail.uc.edu
-
-
Oregon
-
Portland, Oregon, 미국, 97239
- 아직 모집하지 않음
- Oregon Health & Science University
-
연락하다:
- Brian Scottoline, MD, PhD
- 전화번호: (503) 494-8122
- 이메일: scottoli@ohsu.edu
-
-
Washington
-
Seattle, Washington, 미국, 98195
- 모병
- University of Washington
-
연락하다:
- Katie M Strobel, MD, MSCR
- 전화번호: (206) 543-3200
- 이메일: kmstrob@uw.edu
-
부수사관:
- D Taylor Hendrixson, MD, MPH
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body composition by point-of-care ultrasound
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body composition using air-displacement plethysmography
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Anthropometric growth
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Katie Strobel, MD, MSCR, University of Washington
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- STUDY00023657
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 지원 정보 유형
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .