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

5. februar 2009 oppdatert av: 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.

Studieoversikt

Status

Fullført

Detaljert 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

Studietype

Observasjonsmessig

Registrering (Faktiske)

23

Kontakter og plasseringer

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Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

7 måneder til 9 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
1
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
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
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
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
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
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

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Irit Berger, MD

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2007

Studiet fullført (Faktiske)

1. mars 2008

Datoer for studieregistrering

Først innsendt

5. februar 2009

Først innsendt som oppfylte QC-kriteriene

5. februar 2009

Først lagt ut (Anslag)

6. februar 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. februar 2009

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. februar 2009

Sist bekreftet

1. februar 2009

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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