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Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured? (TFO2)

2016년 8월 10일 업데이트: Christoph Fusch, McMaster Children's Hospital

Target Fortification of Breast Milk: The Effect of Different Schedules for Milk Analysis on the Growth and Development of Preterm Infants.

It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth. In the past, the investigators have analyzed the outcomes of breast milk composition when target fortification is done with different analysis schedules. The investigators were able to measure the macronutrient intake for different milk analysis schedules via a theoretical model and show that the more frequent schedules reduce the variation of fortified-breast milk, whereas a reduced schedule leads to a high variation of macronutrients. It was observed that, in all the breast milk samples measured twice per week, infants achieved on average the recommended macronutrients in line with current recommendations. Nonetheless, the model only looks at the macronutrient intake and does not investigates the relationship between macronutrient variation and its effect on growth.

The aim of the current study is to compare a frequent schedule of measurement of macronutrient analysis with a reduced schedule of measurement and to study its affect on growth, protein accretion and metabolic parameter.

연구 개요

연구 유형

중재적

등록 (예상)

56

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Ontario
      • Hamilton, Ontario, 캐나다, L8S 4K1
        • Faculty of Health Science, McMaster Children's Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

6개월 이하 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Gestational age < 30 weeks (maternal dates or early fetal ultrasound);
  2. Tolerating an enteral intake of ≥100 mL/kg/d for ≥ 24h;
  3. Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥150 mL/kg/d) has been achieved;
  4. Written informed consent has been obtained from the infant's legal representative.
  5. Multiple births: Each infant will be included in the study if he/she meets the study criteria, and siblings will be individually randomized to one or other of the treatment arms.
  6. Discussion with Most Responsible Physician (MRP) and the staff in order to discuss any potential transfer during the next 7 days.

Exclusion Criteria:

  1. Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
  2. Babies with enterostoma or short gut syndrome;
  3. Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
  4. Fluid restriction <140 mL/kg/d for ≥ 3 consecutive days;
  5. Sepsis - all infants with gram-negative sepsis will be removed from the study;
  6. Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3);
  7. Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen >10 mmol/L and creatinine of 130mmol/L
  8. Participation in another clinical trial that may provide an alternative nutritional intervention, which might affect the outcomes of this study. outcomes of this study;
  9. Probability of transfer to another neonatal intensive care unit or level II nursery outside the McMaster Children's Hospital, as discussed with the most responsible physician (MRP)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 5 milk analysis
  1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed five times per week, of native breast milk batches which had been prepared for 24 hours feeding.
  2. Routine fortifier will be added to breast milk batches.
  3. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level.
Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.
실험적: 1 milk analysis
  1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed once per week of native breast milk batches which had been prepared for 24 hours feeding.
  2. Routine fortifier will be added to breast milk batches.
  3. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level.
Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Growth during first three weeks of intervention
기간: first three weeks during intervention before 36 weeks of gestation
first three weeks during intervention before 36 weeks of gestation

2차 결과 측정

결과 측정
측정값 설명
기간
Daily Nutrient intake (kcal, lactose, protein, fat) measured with conventional milk analysis
기간: from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation
from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation
Weight Gain
기간: from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation or discharge
from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation or discharge
Oxidative stress by 8-Oxo-2'-deoxyguanosine metabolites in urine
기간: from inclusion at postmenstrual age <30 weeks until discharge
Measured by mass spectroscopy
from inclusion at postmenstrual age <30 weeks until discharge
Protein synthesis analyzed by nitrogen excretion in urine [µmol/mL]
기간: first three weeks during intervention before 36 weeks of gestation
first three weeks during intervention before 36 weeks of gestation
Feeding intolerance questionaire
기간: from inclusion at postmenstrual age <30 weeks until discharge
volume of gastric residuals, color of gastric residuals, vomiting, abdominal girth, abdominal distention
from inclusion at postmenstrual age <30 weeks until discharge
Fat mass [g]
기간: from inclusion at postmenstrual age <30 weeks until discharge
Measured with bioelectrical impedance analysis
from inclusion at postmenstrual age <30 weeks until discharge
Lean mass [g]
기간: from inclusion at postmenstrual age <30 weeks until discharge
Measured with bioelectrical impedance analysis
from inclusion at postmenstrual age <30 weeks until discharge
Head circumference [cm]
기간: from inclusion at postmenstrual age <30 weeks until discharge
Measured by tape
from inclusion at postmenstrual age <30 weeks until discharge
Body length [cm]
기간: from inclusion at postmenstrual age <30 weeks until discharge
Measured by length board
from inclusion at postmenstrual age <30 weeks until discharge

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Christoph Fusch, MD, PhD, McMaster Children's Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2016년 9월 1일

기본 완료 (예상)

2017년 6월 1일

연구 완료 (예상)

2019년 6월 1일

연구 등록 날짜

최초 제출

2016년 8월 8일

QC 기준을 충족하는 최초 제출

2016년 8월 10일

처음 게시됨 (추정)

2016년 8월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 8월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 8월 10일

마지막으로 확인됨

2016년 8월 1일

추가 정보

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아니요

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