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Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

2. marts 2021 opdateret af: Abbott Nutrition

Growth and Compliance of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

320

Kontakter og lokationer

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

Studiesteder

  • Kalkun
      • Adana, Kalkun, 01150
        • Adana City Hospital
      • Afyon, Kalkun, 03200
        • Afyon Kocatepe University Medical Faculty
      • Ankara, Kalkun, 06590
        • Ankara University Medical Faculty
      • Ankara, Kalkun, 06080
        • Ankara Dr. Sami Ulus Women and Child Disesase Research and Training Hospital B
      • Ankara, Kalkun, 06100
        • Hacettepe Üniversitesi University Medical Faculty A
      • Ankara, Kalkun, 06100
        • Hacettepe Üniversitesi University Medical Faculty B
      • Ankara, Kalkun, 06110
        • Ankara Dışkapı Child Disease Hospital A
      • Ankara, Kalkun, 06110
        • Ankara Dışkapı Child Disease Hospital B
      • Ankara, Kalkun, 06230
        • Ankara Research and Training Hospital
      • Ankara, Kalkun, 06370
        • Ankara Yıldırım Beyazıt University Yenimahalle Research and Training Hospital
      • Ankara, Kalkun, 06500
        • Gazi Üniversitesi University Medical Faculty
      • Antalya, Kalkun, 07070
        • Akdeniz University Medical Faculty A
      • Antalya, Kalkun, 07070
        • Akdeniz University Medical Faculty B
      • Balıkesir, Kalkun, 10145
        • Balıkesir University Research and Training Hospital
      • Bursa, Kalkun, 16310
        • TC Sağlık Bilimleri University Bursa Yuksek Intisas Research and Training Hospital
      • Denizli, Kalkun, 20070
        • Pamukkale University Medical Faculty A
      • Denizli, Kalkun, 20070
        • Pamukkale University Medical Faculty B
      • Elazığ, Kalkun, 23119
        • Fırat Üniversitesi University Medical Faculty
      • Erzurum, Kalkun, 25070
        • Erzurum Research and Training Hospital
      • Gaziantep, Kalkun, 27310
        • Gaziantep University Medical Faculty
      • Hatay, Kalkun, 31001
        • Hatay State Hospital
      • Istanbul, Kalkun, 34230
        • Istanbul Esenler Women and Children Diseases Hospital
      • Kocaeli, Kalkun, 41380
        • Kocaeli Üniversitesi University Medical Faculty
      • Konya, Kalkun, 42060
        • Konya Necmettin Erbakan University Medical Faculty
      • Konya, Kalkun, 42080
        • Konya Başkent University Hospital
      • Konya, Kalkun, 42130
        • Konya Selcuk University Medical Faculty
      • Kırıkkale, Kalkun, 71450
        • Kırıkkale University Medical Faculty
      • Malatya, Kalkun, 44280
        • İnönü Üniversitesi University Medical Faculty
      • Samsun, Kalkun, 55040
        • Samsun Research and Training Hospital
      • Trabzon, Kalkun, 61080
        • Karadeniz Teknik University Medical Faculty
      • Trabzon, Kalkun, 61290
        • Trabzon Kanuni Research and Training Hospital
      • Zonguldak, Kalkun, 67000
        • Zonguldak Bülent Ecevit University Research and Training Hospital
      • İstanbul, Kalkun, 34093
        • İstanbul University İstanbul Medical School A
      • İstanbul, Kalkun, 34098
        • Istanbul University Cerrahpasa Medical School
      • İstanbul, Kalkun, 34147
        • İstanbul Bakırköy Dr. Sadi Konuk Research and Training Hospital
      • İstanbul, Kalkun, 34303
        • İstanbul Atakent Acıbadem Hospital
      • İstanbul, Kalkun, 34303
        • İstanbul Kanuni Sultan Süleyman Research and Training Hospital A
      • İstanbul, Kalkun, 34371
        • İstanbul Sisli Hamidiye Etfal Research and Training Hospital C
      • İstanbul, Kalkun, 34371
        • İstanbul Şişli Hamidiye Etfal Research and Training Hospital A
      • İstanbul, Kalkun, 34371
        • İstanbul Şişli Hamidiye Etfal Research and Training Hospital B
      • İstanbul, Kalkun, 34384
        • İstanbul Okmeydanı Research and Training Hospital
      • İstanbul, Kalkun, 34457
        • İstanbul Maslak Acıbadem Hospital
      • İstanbul, Kalkun, 34662
        • İstanbul Altunizade Acıbadem Hospital
      • İstanbul, Kalkun, 34722
        • İstanbul Göztepe Research and Training Hospital
      • İstanbul, Kalkun, 34764
        • İstanbul Ümraniye Research and Training Hospital A
      • İstanbul, Kalkun, 34764
        • İstanbul Ümraniye Research and Training Hospital B

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 sekund til 5 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects will be enrolled from outpatient clinics and physician offices.

Beskrivelse

Inclusion Criteria:

  • Infant is experiencing persistent feeding intolerance or allergy and diagnosed wtih Cow's Milk Protein Allergy (CMPA) or other condition where an extensively hydrolyzed formula is deemed appropriate by their healthcare professional
  • Infants using OTC medications, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance
  • Parent(s) of infants enrolled on prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids directed by their healthcare professional, confirm their intention to continue their use during the study until directed by their healthcare professional to discontinue.
  • Infant is not receiving steroids.
  • Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
  • Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study
  • Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrollment through the duration of the study
  • Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB)

Exclusion Criteria:

  • Participation in another study that has not been approved as a concomitant study by AN

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
Weight
Tidsramme: Baseline to Study Day 30
Measured in Kg
Baseline to Study Day 30

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Formula Intake
Tidsramme: Baseline to Study Day 30
Parent completed diary
Baseline to Study Day 30

Samarbejdspartnere og efterforskere

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

Sponsor

Abbott Nutrition

Efterforskere

  • Studiestol: Aysugul Alptekin, MD, Abbott Turkey

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)

31. januar 2018

Primær færdiggørelse (Faktiske)

27. marts 2020

Studieafslutning (Faktiske)

27. marts 2020

Datoer for studieregistrering

Først indsendt

13. juli 2018

Først indsendt, der opfyldte QC-kriterier

13. juli 2018

Først opslået (Faktiske)

24. juli 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • DA16

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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 Gastrointestinal tolerance

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Poland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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