Évaluation de l'utilisation de sacs en plastique pour prévenir l'hypothermie néonatale-Partie I
Évaluation randomisée de l'utilisation de sacs en plastique pour prévenir l'hypothermie néonatale dans les pays en développement - Partie I
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Lusaka, Zambie
- University Teaching Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
- Delivery in the hospital
Exclusion Criteria:
- Infant admitted to the NICU
- Birth weight less than 1,400g
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Resuscitation-torso plastic bag
Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation. |
Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth. |
|
Comparateur actif: Resuscitation-partial-head plastic bag
Resuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation. |
Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Axillary temperature < 36.5 degrees Celsius
Délai: 1-72 hours after birth
|
Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and < 32.0 will be classified as severe hypothermia |
1-72 hours after birth
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Seizure
Délai: Up to 4 weeks
|
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done. |
Up to 4 weeks
|
|
Respiratory Distress Syndrome (RDS)
Délai: Up to 4 weeks
|
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant |
Up to 4 weeks
|
|
Pneumothorax
Délai: Up to 4 weeks
|
Either chest radiograph documentation or clinical deterioration consistent with air leak |
Up to 4 weeks
|
|
Sepsis
Délai: Up to 4 weeks
|
Culture proven or culture negative clinically treated course consistent with sepsis |
Up to 4 weeks
|
|
Necrotizing enterocolitis or intestinal perforation
Délai: Up to 4 weeks
|
Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's classification stage greater than one. |
Up to 4 weeks
|
|
Death
Délai: Up to 4 weeks
|
Cardiorespiratory failure |
Up to 4 weeks
|
|
Hyperthermia
Délai: Up to 4 weeks
|
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute |
Up to 4 weeks
|
|
Temperature and humidity
Délai: 1-72 hours after birth
|
A recording of the room temperature and humidity will be obtained with each axillary temperature measurement |
1-72 hours after birth
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Waldemar A Carlo, MD, University of Alabama at Birmingham
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
- UAB Neo 005
- Perinatal Health/Human (Autre identifiant: University of Alabama at Birmingham)
- Childrens Centennial (Autre identifiant: Childrens of Alabama)
- Caduceus Club (Autre identifiant: University of Alabama School of Medicin)
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