Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides (PLATYPUS)

18. december 2020 opdateret af: Société des Produits Nestlé (SPN)

Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides: Comparison With World Health Organization (WHO) Growth Standards in an Observational, Single-arm Study

The main aim of this study is to provide longitudinal growth data in infants with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

33

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • Westmead
      • Sydney, Westmead, Australien, 2145
        • The Children's Hospital at Westmead

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 måned til 8 måneder (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Full-term infants 1-8 months of age with symptoms suggestive of moderate-to-severe CMPA who have failed a trial of extensively hydrolyzed formula (EHF) of at least 2 weeks or who require amino acid formula as first line of treatment

Beskrivelse

Inclusion Criteria:

  1. Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
  2. 2500g ≤ birth weight ≤ 4500g
  3. Having obtained written informed consent form the infant's parents or legally authorized representatives (LAR).
  4. Infant aged between 1 and 8 months.
  5. Exclusively formula-fed at time of enrolment; or CMPA infant receiving partial breastfeeding and infant's mother having independently elected before enrolment to exclusively formula feed.
  6. Infants with physician-diagnosed CMPA as per standard clinical practice:

Exclusion Criteria:

  1. Previous treatment with AAF > 72 hours
  2. Known underlying medical condition that would impair growth (as per physician's assessment, e.g. unstable congenital heart disease, cystic fibrosis, metabolic disorder, chronic liver disease etc.)
  3. Demonstrated chronic malabsorption which is not due to CMPA.
  4. Other significant pre-natal and/or serious post-natal disease other than CMPA before enrolment (per investigator's medical decision).
  5. Infants whose parents or caregivers who cannot give informed consent or who cannot be expected to comply with study procedures.
  6. Treatment with systemic corticosteroids (oral or intravenous) for >72 hours within 4 weeks before enrolment (topical corticosteroids allowed)
  7. Infants taking probiotic preparations for > 72 hour within 4 weeks before enrolment
  8. Currently participating or having participated in another clinical trial since birth.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The weight-for-age z-score (WAZ) compared with the WHO 2006 Child Growth Standard
Tidsramme: Comparison of baseline WAZ vs WAZ at 4 months
Weight gain will be measured in kg and converted to WAZ scores
Comparison of baseline WAZ vs WAZ at 4 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length-for-age Z-scores (LAZ) compared with the WHO 2006 Child Growth Standard
Tidsramme: 1, 2, 3, 4 months from baseline and at 12 months of age
Body length will be measured in cm and converted to LAZ scores
1, 2, 3, 4 months from baseline and at 12 months of age

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Head circumference (HCAZ) compared with the WHO 2006 Child Growth Standard
Tidsramme: 1, 2, 3, 4 months from baseline and at 12 months of age
Head circumference will be measured in cm converted to HCAZ scores
1, 2, 3, 4 months from baseline and at 12 months of age
Monitoring of CMPA-related symptoms
Tidsramme: 1, 2, 3 and 4 months from baseline and at 12 months of age
CMPA-related symptoms will be documented by the study physician on data collection forms
1, 2, 3 and 4 months from baseline and at 12 months of age
Faecal microbial composition
Tidsramme: Enrolment,1, 2, 3 and 4 months from treatment start and also at 12 months of age
Faecal samples will be collected before and after the study formula ingestion
Enrolment,1, 2, 3 and 4 months from treatment start and also at 12 months of age
Product compliance
Tidsramme: 1, 2, 3 and 4 months from baseline and at 12 months of age
Daily quantity consumed (mL) will be recorded for the 3 days preceding each visit in a diary given to the parent or caregiver
1, 2, 3 and 4 months from baseline and at 12 months of age

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Société des Produits Nestlé (SPN)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. april 2018

Primær færdiggørelse (Faktiske)

30. oktober 2020

Studieafslutning (Faktiske)

30. oktober 2020

Datoer for studieregistrering

Først indsendt

22. august 2018

Først indsendt, der opfyldte QC-kriterier

5. september 2018

Først opslået (Faktiske)

7. september 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. december 2020

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 17.09.CLI

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Komælksallergi

Kliniske forsøg med Food for Specific Medical Purpose

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Italy

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner