Evaluatie van het gebruik van plastic zakken om hypothermie bij pasgeborenen te voorkomen - Deel I
Gerandomiseerde evaluatie van het gebruik van plastic zakken om onderkoeling bij pasgeborenen in ontwikkelingslanden te voorkomen - Deel 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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%.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Lusaka, Zambia
- University Teaching Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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. |
|
Actieve vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Axillary temperature < 36.5 degrees Celsius
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Seizure
Tijdsspanne: Up to 4 weeks
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Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done. |
Up to 4 weeks
|
|
Respiratory Distress Syndrome (RDS)
Tijdsspanne: Up to 4 weeks
|
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant |
Up to 4 weeks
|
|
Pneumothorax
Tijdsspanne: Up to 4 weeks
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Either chest radiograph documentation or clinical deterioration consistent with air leak |
Up to 4 weeks
|
|
Sepsis
Tijdsspanne: Up to 4 weeks
|
Culture proven or culture negative clinically treated course consistent with sepsis |
Up to 4 weeks
|
|
Necrotizing enterocolitis or intestinal perforation
Tijdsspanne: 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
|
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Death
Tijdsspanne: Up to 4 weeks
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Cardiorespiratory failure |
Up to 4 weeks
|
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Hyperthermia
Tijdsspanne: Up to 4 weeks
|
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute |
Up to 4 weeks
|
|
Temperature and humidity
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Waldemar A Carlo, MD, University of Alabama at Birmingham
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UAB Neo 005
- Perinatal Health/Human (Andere identificatie: University of Alabama at Birmingham)
- Childrens Centennial (Andere identificatie: Childrens of Alabama)
- Caduceus Club (Andere identificatie: University of Alabama School of Medicin)
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