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

Growth and Tolerance of Infants Fed Infant Formulas

30. maj 2014 opdateret af: Abbott Nutrition

Growth and Tolerance of Young Infants Fed Infant Formulas

To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

424

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • Alabama Clinical Therapeutics, LLC
      • Dothan, Alabama, Forenede Stater, 36305
        • Alabama Clinical Therapeutics
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85712
        • W.O.M.B Watching Over Mothers and Babies
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80920
        • Clinical Research Advantage/Colorado Springs Health Partners
    • Connecticut
      • Norwich, Connecticut, Forenede Stater, 06360
        • Norwich Pediatric Group, PC
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33472
        • Atlantic Clinical Research Collaborative
      • Orange City, Florida, Forenede Stater, 32763
        • Lake Mary Pediatrics
      • St. Petersburg, Florida, Forenede Stater, 33710
        • SCORE Physician Alliance, LLC
      • Tampa, Florida, Forenede Stater, 33606
        • USF, College of Medicine, Dept of Pediatrics
    • Georgia
      • Columbus, Georgia, Forenede Stater, 31904
        • Southeast Regional Research Group (SERRG)
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47720
        • PediaResearch, LLC
      • Indianapolis, Indiana, Forenede Stater, 46256
        • Northpoint Pediatrics, LLC
      • Lafayette, Indiana, Forenede Stater, 47905
        • Lafayette Clinical Research
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Women's Clinic of Lincoln, PC
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44109
        • MetroHealth Medical Center
      • Dayton, Ohio, Forenede Stater, 45406
        • Dayton Clinical Research
      • Dayton, Ohio, Forenede Stater, 45414
        • Ohio Pediatric Research Association, Inc
      • Mayfield Heights, Ohio, Forenede Stater, 44124
        • Institute of Clinical Research
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401
        • Clinical Trials of America
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
        • Red Lion Pediatrics
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 65104
        • Sanford Research
    • Utah
      • Layton, Utah, Forenede Stater, 84041
        • Tanner Memorial Clinic
    • Washington
      • Spokane, Washington, Forenede Stater, 99202
        • Rockwood Clinic, PS
  • Puerto Rico
      • Guayama, Puerto Rico, 00784
        • Clinical Research Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine/ CAIMED Center

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

Ikke ældre end 5 dage (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Singleton from full term birth with a gestational age 37-42 weeks
  • Birth weight > 2490 g (~5 lbs 8 oz)
  • Between 0 and 5 days of age
  • Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
  • Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
  • Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
  • No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional

Exclusion Criteria:

  • Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
  • Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
  • Treatment with antibiotics
  • Mother intends to use a combination of breast and formula feeding

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Human Milk
Reference group, breast feeding ad libitum
Andet: Human Milk
Feeding ad libitum
Andre navne:
  • Breast feeding group
Aktiv komparator: Control Formula
Ready to feed infant formula, feed ad libitum
Andet: Control Formula
Feeding ad libitum
Andre navne:
  • Commercially available Infant Formula
Eksperimentel: Experimental Formula 1
Ready to feed infant formula with human milk oligosaccharides, feed ad libitum
Andet: Experimental Formula 1
Feeding ad libitum
Eksperimentel: Experimental Formula 2
Ready to feed infant formula with human milk oligosaccharides, feed ad libitum
Andet: Experimental Formula 2
Feeding ad libitum

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight
Tidsramme: Study Day (SD) 14 - 119
Weight gain per day
Study Day (SD) 14 - 119

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stool Characteristics
Tidsramme: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Stool consistency and number per day
Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Feeding Tolerance
Tidsramme: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
% of feedings with spit up associated with feeding
Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Length
Tidsramme: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
Length and interval length gain per day
Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
Head Circumference
Tidsramme: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
Head circumference (HC) and interval HC gain per day
Study Day (SD) 1, 14, 28, 42, 84 and 119 visits

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Study Formula Intake
Tidsramme: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Average volume of study formula intake and average number of study formula feedings per day
Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Oligosaccharides
Tidsramme: Study Day (SD) 42 and 119 visits
Infant urine sample
Study Day (SD) 42 and 119 visits

Samarbejdspartnere og efterforskere

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

Sponsor

Abbott Nutrition

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. april 2013

Primær færdiggørelse (Faktiske)

1. februar 2014

Studieafslutning (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først indsendt

7. marts 2013

Først indsendt, der opfyldte QC-kriterier

7. marts 2013

Først opslået (Skøn)

11. marts 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • AL06

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 Vækst og tolerance

Kliniske forsøg med Human Milk

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Burundi

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner