- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01069731
Comparison of Non-nutritive Suck (NNS) Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants
Comparison of NNS Performance Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants Using the NTrainer Device
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Fifteen minutes before feeding, the mobile NTrainer recording station will be positioned cribside. Following a brief exam of physiologic state, using the Oral Feeding Readiness Assessment portion of the EFS, the infant will be cradled in a supportive inclined posture, swaddled, with limbs positioned at midline, and background/overhead lighting dimmed in the area to promote eye contact with the tester. Sampling of NNS behavior will not be initiated until the infant is in an optimal behavioral state, i.e., drowsy to active alert (state 3 or 4 or 5 as described by the Naturalistic Observation of Newborn Behavior, Newborn Individualized Developmental Care and Assessment Program; NIDCAP). The infant will be presented with the NTrainer pacifier, and several contiguous 30-second blocks of NNS nipple compression data will be sampled using the NeoSuck RT software. The infant will remain connected to the usual NICU monitors at all times for observation of respiration, heartbeat and oxygen saturation.
After the NTrainer data collection is completed, the baby will be fed by his or her nurse or parents as directed in the care plan. If the baby is able to feed by mouth, one of the investigators will observe the feeding, and perform 1) a NOMAS evaluation during the first 2 minutes of the feeding, and 2) an EFS assessment after the feeding is completed.
Infants will be studied in 2 sessions each day beginning at Day 4 to 7 of life, then twice weekly (2 sessions per day, 2 days per week) until hospital discharge.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
North Carolina
-
Raleigh, North Carolina, États-Unis, 27610
- WakeMed
-
-
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:
- Born at 30 to 36 weeks gestation and have no exclusion criteria.
Exclusion Criteria:
- Significant birth defects.
- Breathing difficulties severe enough to require being on a ventilator or nasal CPAP for more than 2 hours after birth.
- Any oxygen requirement at Day 4 of life.
- Any neurologic problems, including seizures or frequent apnea spells.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
Infants born at 30 to 36 weeks gestation
Infants will be considered eligible if they are born at 30 to 36 weeks gestation and have no exclusion criteria.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
To describe NNS pressure waveforms and NNS-STI values in normal premature infants with gestational ages 30 to 36 weeks during the first week of life.
Délai: First Weeks of Life
|
First Weeks of Life
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
To describe the progression of NNS waveform pattern and NNS-STI values in normal premature infants as they mature to term postmenstrual age.
Délai: Mature to full term postmenstrual age
|
Mature to full term postmenstrual age
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Thomas Young, MD, WakeMed Health and Hospitals
Publications et liens utiles
Publications générales
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
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
- WakeMed Study 748
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .