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

Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates

14. juni 2018 opdateret af: Colm Travers, University of Alabama at Birmingham
The primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The proposed trial is designed to test the primary hypothesis that in preterm infants weighing 1001-2500 grams at birth and who are less than or equal to 32 weeks gestation, feeding goals of 180-200 ml/kg/day will increase weight gain (g/k/day) from time of enrollment to discharge home or 36 weeks post-menstrual age (PMA)(whichever comes first) more than the commonly used feeding goal volume of 140-160 ml/kg/day (usual feeding goal). This is a pilot study to determine the safety of increased volumes of feedings as opposed to fortification of feedings.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

224

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, 35249
        • University of Alabama at Birmingham

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 dag til 1 måned (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Inborn or outborn infants born at a gestational age of 32 weeks or less; Birthweight 1001-2500; Feeding volume of at least 120 ml/kg/day; Enrolled prior to 28 days of age and prior to exceeding 32 weeks

Exclusion Criteria:

  • Hemodynamically significant patent ductus arteriosis; History of necrotizing enterocolitis Bell Stage II or greater; Known gastrointestinal or neurologic malformations; Prior or planned enrollment into the NICHD MILK Trial; Terminal illness or decision to withhold or limit support

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Higher Volume Feeding Goal
Infants randomized to this group will have higher volume feeding goals of 180-200 ml/kg/day.
Andet: Higher Volume Feeding Goal
feeding volume goal of 180-200 ml/kg/day
Ingen indgriben: Usual Volume Feeding Goal
Infants randomized to this group will have feeding goals of 140-160 ml/kg/day.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight gain
Tidsramme: baseline to average 12 weeks of age
Average change in weight between baseline and 12 weeks
baseline to average 12 weeks of age

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mid arm circumference
Tidsramme: baseline to average 12 weeks of age
average change in mid arm circumference between baseline and 12 weeks
baseline to average 12 weeks of age
Length
Tidsramme: baseline to average 12 weeks of age
average change in length between baseline and 12 weeks
baseline to average 12 weeks of age
Head circumference
Tidsramme: baseline to average 12 weeks of age
average change in head circumference between baseline and 12 weeks
baseline to average 12 weeks of age
Caloric intake
Tidsramme: 36 weeks
Average difference in weekly caloric intake between groups
36 weeks
Length of stay
Tidsramme: 36 weeks or discharge
Days from study entry to discharge home
36 weeks or discharge
Rates of infants less than 10th percentile for weight
Tidsramme: 36 weeks or discharge
Rates of infants less than 10th percentile for weight at study completion
36 weeks or discharge
Change in weight z score
Tidsramme: 36 weeks or discharge
Change in weight z score from study entry to completion
36 weeks or discharge
Change in length z score
Tidsramme: 36 weeks or discharge
Change in length z score from study entry to completion
36 weeks or discharge
Change in head circumference z score
Tidsramme: 36 weeks or discharge
Change in head circumference z score from study entry to completion
36 weeks or discharge

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body fat composition
Tidsramme: 36 weeks or discharge
Percentage of body fat composition
36 weeks or discharge
Rates of necrotizing enterocolitis (Bell Stage ≥ 2)
Tidsramme: 36 weeks or discharge
Safety outcome: Rates of necrotizing enterocolitis (Bell Stage ≥ 2)
36 weeks or discharge
Rates of feeding intolerance
Tidsramme: 36 weeks or discharge
Safety outcome: Rates of feeding intolerance defined as withholding feeds for > 24 hours due to gastrointestinal cause after study entry
36 weeks or discharge
Rates of culture proven sepsis
Tidsramme: 36 weeks or discharge
Safety outcome: Rates of blood culture positive sepsis after study entry
36 weeks or discharge
Duration of respiratory support
Tidsramme: 36 weeks or discharge
Safety outcome: Duration of respiratory support (oxygen, continuous positive airway pressure/high flow nasal cannula/mechanical ventilation) after study entry
36 weeks or discharge
Rates of bronchopulmonary dysplasia
Tidsramme: 36 weeks or discharge
Safety outcome: Rates of bronchopulmonary dysplasia
36 weeks or discharge
Rates of moderate to large or symptomatic patent ductus arteriosus
Tidsramme: 36 weeks or discharge
Safety outcome: Rates of moderate to large or symptomatic patent ductus arteriosus after study entry
36 weeks or discharge
Rates of adverse safety outcomes combined
Tidsramme: 36 weeks or discharge
Safety outcome: Safety outcome: Rates of bronchopulmonary dysplasia, necrotizing enterocolitis ≥ stage 2, feeding intolerance, culture proven sepsis, patent ductus arteriosus after study entry
36 weeks or discharge

Samarbejdspartnere og efterforskere

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

Sponsor

University of Alabama at Birmingham

Efterforskere

  • Ledende efterforsker: Colm Travers, MD, University of Alabama at Birmingham
  • Ariel A Salas, MD, University of Alabama at Birmingham

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. januar 2015

Primær færdiggørelse (Faktiske)

1. juni 2018

Studieafslutning (Faktiske)

1. juni 2018

Datoer for studieregistrering

Først indsendt

1. december 2014

Først indsendt, der opfyldte QC-kriterier

24. februar 2015

Først opslået (Skøn)

3. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • UAB NEO 013

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 For tidligt spædbarn

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Serbia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner