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Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk

5. februar 2009 opdateret af: Tel-Aviv Sourasky Medical Center

OBJECTIVE. Neonatologists consider early feeding at the breast to be too tiring for preterm infants, although there is no evidence that this is actually the case. It is also not known whether the method of feeding affects energy expenditure. We hypothesized that resting energy expenditure (REE) would be higher after breastfeeding than after bottle feeding.

PATIENTS AND METHODS. preterm ( >32 weeks GA) stable infants who are nourished entirely by their mothers' breast milk will be studied when fed expressed breast milk either by bottle or at the breast. REE will be measured for 20 minutes after feeding. Breast milk quantity is evaluated by pre- and post feeding weighing.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Most VLBW infants cannot be fed at the breast upon birth, and expressed breast milk by gastric tube is thus recommended. Sucking skills mature at around 34 weeks when nipple-feeding is introduced. In the absence of evidence-based data to decide the best timing to introduce breastfeeding, many clinicians use empiric criteria, such as the infant's weight, gestational age, and the ability of infants to bottle feed as proxies of readiness to breastfeed. Despite some evidence of physiological benefits of preterm infants feeding at the breast, many neonatologists consider direct breastfeeding to be too fatiguing for preterm infants. It is not known, however, whether preterm infants who are breastfed expend more energy than bottle-fed infants

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

23

Kontakter og lokationer

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

Studiesteder

  • Israel
      • Tel Aviv, Israel
        • Department of Neonatology, Tel Aviv Sourasky Medical Center
      • Tel-Aviv, Israel
        • Sourasky Medical 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

7 måneder til 9 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Preterm infants born after 32 weeks of gestation, when they reached the corrected gestational age of 34 weeks or more.

Beskrivelse

Inclusion Criteria:

  • Thermally stable infants were nursed in an open and unwarmed bassinet.
  • All fed solely by their mothers' breast milk equivalent to at least 150 cc/kg/day divided into eight meals and growing steadily

Exclusion Criteria:

  • Infants with congenital anomalies and infants who had either more than five daily episodes of apnea of prematurity or any apnea requiring assistance or methylxanthine therapy

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
1
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Andet: Way of Feeding - Breast feeding vs. Bottle feeding
Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast. Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
2
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Andet: Way of Feeding - Breast feeding vs. Bottle feeding
Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast. Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Breast - feeding first
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Andet: Way of Feeding - Breast feeding vs. Bottle feeding
Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast. Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Bottle first
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Andet: Way of Feeding - Breast feeding vs. Bottle feeding
Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast. Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Way of feeding
Each infant is evaluated twice, once after breastfeeding and once after bottle feeding of breast milk using a Premature Nipple & Ring (Ross Products Division, Columbus OH, USA). In this way, each infant serves as its own control. REE is recorded for 20 minutes after each meal
Andet: Way of Feeding - Breast feeding vs. Bottle feeding
Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast. Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The primary goal of this study was to compare resting energy expenditure (REE) in preterm infants who were fed their mothers' expressed milk by bottle and at the breast
Tidsramme: 20 minutes after each meal
20 minutes after each meal

Sekundære resultatmål

Resultatmål
Tidsramme
Creamatocrit of the bottle at the beginning and the completion of every feeding at the breast were measured
Tidsramme: Not relevant
Not relevant

Samarbejdspartnere og efterforskere

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

Sponsor

Tel-Aviv Sourasky Medical Center

Efterforskere

  • Ledende efterforsker: Irit Berger, MD

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. november 2007

Studieafslutning (Faktiske)

1. marts 2008

Datoer for studieregistrering

Først indsendt

5. februar 2009

Først indsendt, der opfyldte QC-kriterier

5. februar 2009

Først opslået (Skøn)

6. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. februar 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. februar 2009

Sidst verificeret

1. februar 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 920060356

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 fødte spædbørn

Kliniske forsøg med Way of Feeding - Breast feeding vs. Bottle feeding

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