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Preterm Infants May Better Tolerate Warmer Feeds (Prematurity)

13. november 2018 opdateret af: Ozge Altun Koroglu, Ege University

Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk- A Randomized Controlled Trial

Feeding intolerance is frequent among preterm infants in neonatal intensive care units (NICUs). Although there are many studies about enteral nutrition strategies and content in preterm infants, no evidence-based standards exist for the optimal milk temperature for preterm infants. Therefore, in this study the investigators aimed to examine the effects of feeding temperature and the possible morbidities.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Feeding intolerance is one of the most frequent problems among preterm infants. These infants are fed with expressed breast milk or preterm formulas of which the temperature is not routinely measured. In this study, the investigators aimed to examine the effects of feeds with warm versus room temperature milk in preterm infants. Infants with a birth weight of ≤1500 g or gestational age of ≤ 34 weeks were included in the study and assigned to two different feeding temperature groups (22-24°C and 32-34°C). Some infants in both groups were exclusive breast milk fed and some received artificial milk. Feeding tolerance of patients in both groups and the consequences were evaluated.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Kalkun
      • İzmir, Kalkun
        • Ege University

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 4 uger (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Infants born to birth weight of ≤1500 g
  • Infants born to gestational age of ≤ 34 weeks

Exclusion Criteria:

  • Genetic syndrome
  • Gastrointestinal system anomalies
  • Patients born small for their gestational age

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Room temperature
All of the infants in neonatal intensive care units are used to be fed with milk at 22-24°C which is close to room temperature.
Andet: Room temperature
These infants were fed with room temperature (22-24 °C) so that hypothesizing that they will have more feeding tolerance and therefore more co-existing morbidities.
Eksperimentel: Warmer temperature
The investigators decided to feed the infants in this group with warmer milk at to examine the effects of feeding temperature.
Andet: Warmer temperature
Fifteen NICU mothers volunteered and expressed their milk for rapid measurement of freshly expressed breast milk. The mean (± SD) temperature of freshly expressed breast milk was found to be 33±1.5 °C in these preliminary measurements. Confirming this finding, the investigators decided to feed these infants with milk at 32 - 34 °C to examine the effects of feeding temperature and the possible comorbidities with a hypothesis that warmer feeding at the temperature of freshly expressed breast milk may be better physiologically.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gastric residual volume in mililitres after every feeding
Tidsramme: through study completion, an average of 6 months
Gastric residual volume amount during the study
through study completion, an average of 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Transition time to total enteral feeding
Tidsramme: through study completion, an average of 6 months
The time needed for transition time to total enteral feeding
through study completion, an average of 6 months
Daily weight gain
Tidsramme: through study completion, an average of 6 months
The daily weight gain of the infant during the study
through study completion, an average of 6 months
Need for anti reflux treatment
Tidsramme: through study completion, an average of 6 months
ıf the infant needed antireflux treatment, the treatment options were recorded
through study completion, an average of 6 months
Body weight at discharge
Tidsramme: through study completion, an average of 6 months
Body weight at discharge
through study completion, an average of 6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Ege University

Efterforskere

  • Studiestol: Ozge Altun Koroglu, M.D., Ege University

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)

1. oktober 2012

Primær færdiggørelse (Faktiske)

30. april 2014

Studieafslutning (Faktiske)

30. april 2014

Datoer for studieregistrering

Først indsendt

30. oktober 2018

Først indsendt, der opfyldte QC-kriterier

13. november 2018

Først opslået (Faktiske)

16. november 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EGE20121284

Plan for individuelle deltagerdata (IPD)

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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 Præmaturitet

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Betingelser

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Placeringer

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