- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Tel Aviv, Israël
- Department of Neonatology, Tel Aviv Sourasky Medical Center
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Tel-Aviv, Israël
- Sourasky Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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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
Délai: 20 minutes after each meal
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20 minutes after each meal
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Creamatocrit of the bottle at the beginning and the completion of every feeding at the breast were measured
Délai: Not relevant
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Not relevant
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Irit Berger, MD
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 920060356
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