- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00838188
Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk
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.
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Iscrizione (Effettivo)
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Luoghi di studio
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Tel Aviv, Israele
- Department of Neonatology, Tel Aviv Sourasky Medical Center
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Tel-Aviv, Israele
- Sourasky Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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1
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
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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
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2
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
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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
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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
|
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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
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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
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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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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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
Lasso di tempo: 20 minutes after each meal
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20 minutes after each meal
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Creamatocrit of the bottle at the beginning and the completion of every feeding at the breast were measured
Lasso di tempo: Not relevant
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Not relevant
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Irit Berger, MD
Pubblicazioni e link utili
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Altri numeri di identificazione dello studio
- 920060356
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Neonati prematuri
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Brigham and Women's HospitalBoston Children's HospitalReclutamentoPretermine Meno Di 32 Settimane Con IVH, WMI/PVL | Late Preterm o Term (37-42 settimane) Con Encefalopatia Neonatale Trattata Con Ipotermia per HIEStati Uniti
Prove cliniche su Way of Feeding - Breast feeding vs. Bottle feeding
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Emory UniversityChildren's Healthcare of AtlantaCompletatoDisturbi dell'alimentazione e dell'alimentazione | Disturbo dell'assunzione di cibo evitante/restrittivo | Disturbi dell'alimentazioneStati Uniti