Bewertung der Verwendung von Plastiktüten zur Vorbeugung von neonataler Hypothermie – Teil I
Randomisierte Bewertung der Verwendung von Plastiktüten zur Vorbeugung von neonataler Hypothermie in Entwicklungsländern – Teil 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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%.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
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Lusaka, Sambia
- University Teaching Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 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. |
|
Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Axillary temperature < 36.5 degrees Celsius
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Seizure
Zeitfenster: 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)
Zeitfenster: Up to 4 weeks
|
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant |
Up to 4 weeks
|
|
Pneumothorax
Zeitfenster: Up to 4 weeks
|
Either chest radiograph documentation or clinical deterioration consistent with air leak |
Up to 4 weeks
|
|
Sepsis
Zeitfenster: Up to 4 weeks
|
Culture proven or culture negative clinically treated course consistent with sepsis |
Up to 4 weeks
|
|
Necrotizing enterocolitis or intestinal perforation
Zeitfenster: 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
Zeitfenster: Up to 4 weeks
|
Cardiorespiratory failure |
Up to 4 weeks
|
|
Hyperthermia
Zeitfenster: Up to 4 weeks
|
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute |
Up to 4 weeks
|
|
Temperature and humidity
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Waldemar A Carlo, MD, University of Alabama at Birmingham
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Geschätzt)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UAB Neo 005
- Perinatal Health/Human (Andere Kennung: University of Alabama at Birmingham)
- Childrens Centennial (Andere Kennung: Childrens of Alabama)
- Caduceus Club (Andere Kennung: University of Alabama School of Medicin)
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