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

10. august 2016 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Forventet)

56

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 6 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Growth during first three weeks of intervention
Tidsramme: first three weeks during intervention before 36 weeks of gestation
first three weeks during intervention before 36 weeks of gestation

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Daily Nutrient intake (kcal, lactose, protein, fat) measured with conventional milk analysis
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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]
Tidsramme: first three weeks during intervention before 36 weeks of gestation
first three weeks during intervention before 36 weeks of gestation
Feeding intolerance questionaire
Tidsramme: 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]
Tidsramme: 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]
Tidsramme: 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]
Tidsramme: from inclusion at postmenstrual age <30 weeks until discharge
Measured by tape
from inclusion at postmenstrual age <30 weeks until discharge
Body length [cm]
Tidsramme: from inclusion at postmenstrual age <30 weeks until discharge
Measured by length board
from inclusion at postmenstrual age <30 weeks until discharge

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2016

Primær fullføring (Forventet)

1. juni 2017

Studiet fullført (Forventet)

1. juni 2019

Datoer for studieregistrering

Først innsendt

8. august 2016

Først innsendt som oppfylte QC-kriteriene

10. august 2016

Først lagt ut (Anslag)

15. august 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. august 2016

Sist bekreftet

1. august 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2016TFO2

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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