Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
18. februar 2019 opdateret af: Wally Carlo, University of Alabama at Birmingham
Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part III
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 III is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Incubators in the developing world often lack humidifiers.
The resting dry heat increases evaporative heat loss, the most prominent form of heat loss in premature infants due to their increased body surface area and immature stratum corneum.
By potentially increasing humidity around the infants and decreasing evaporative heat losses, plastic bags may improve incubator warming.
This study will compare the incidence of hypothermia in infants placed in an incubator for at least one hour randomized to receive standard incubator protocol (control group) or standard incubator protocol plus a plastic bag covering their torsos and lower extremities (intervention group).
The axillary temperature of each infant will be taken before placement into the incubator and one hour later when the bag will be removed.
Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage, incubator temperature, and humidity, and length of time in an incubator will be recorded throughout the hospitalization for all infants.
With an estimated baseline hypothermia rate of 90% and a hypothesized 20% absolute risk reduction (22% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.
Undersøgelsestype
Interventionel
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Lusaka, Zambia
- University Teaching Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 minut til 3 dage (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Infant admitted to the NICU
- Current weight between 1,000 and 2,500g
- Being placed in an incubator
Exclusion Criteria:
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Sham-komparator: Incubator-no plastic bag
Placement into an incubator without a plastic bag
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Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.
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Aktiv komparator: Incubator-torso bag
Placement into a plastic bag inside incubator
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While being placed into an incubator, infant will be placed into a plastic bag to his/her axillae and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth.
The infant will be wrapped in a blanket over the plastic bag and will receive a cloth hat.
He/she will remain in the bag for one hour.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Axillary temperature 36.5-37.5 degrees Celsius
Tidsramme: 1-72 hours
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Temperature taken per axilla for 1 minute
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1-72 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Anfald
Tidsramme: Op til 4 uger
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Anfaldsaktivitet diagnosticeret af læge eller sygeplejerske.
Der vil ikke blive foretaget et elektroencefalogram.
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Op til 4 uger
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Pneumothorax
Tidsramme: Op til 4 uger
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Enten røntgendokumentation af thorax eller klinisk forringelse i overensstemmelse med luftlækage
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Op til 4 uger
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Sepsis
Tidsramme: Op til 4 uger
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Kultur bevist eller kulturnegativ klinisk behandlet forløb i overensstemmelse med sepsis
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Op til 4 uger
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Død
Tidsramme: Op til 4 uger
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Kardiorespiratorisk svigt
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Op til 4 uger
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Hypertermi
Tidsramme: Op til 4 uger
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Akseltemperatur > 38 grader Celsius pr. temperatur taget pr. aksill i et minut
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Op til 4 uger
|
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Blood glucose
Tidsramme: Up to 4 weeks
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Measure of blood glucose per laboratory value taken per heel stick
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Up to 4 weeks
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Weight gain
Tidsramme: Up to 4 weeks
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Infant will be weighed daily and rates of weight gain will be calculated
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Up to 4 weeks
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Major brain injury
Tidsramme: Up to 4 weeks
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Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
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Up to 4 weeks
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Pulmonary hemorrhage
Tidsramme: Up to 4 weeks
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Blood seen in the endotracheal tube and treated by physician
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Up to 4 weeks
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Blood Pressure
Tidsramme: Up to 4 weeks
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Measure of extremity blood pressure per cuff taken during nursery stay
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Up to 4 weeks
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Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome (RDS)
Tidsramme: Up to 4 weeks
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Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
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Up to 4 weeks
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Bronchopulmonary dysplasia (BPD)
Tidsramme: 28 days after birth
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Oxygen requirement at 28 days after birth
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28 days after birth
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Necrotizing enterocolitis or intestinal perforation
Tidsramme: Up to 4 weeks
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Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocoliities per Bell's Classification stage greater than 1.
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Up to 4 weeks
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Length of time in Incubator
Tidsramme: Up to 4 weeks
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Documentation of length of time spent in incubator and number of times placed in incubator
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Up to 4 weeks
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Temperature and humidity
Tidsramme: 1 hour
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A recording of the air temperature and humidity within the incubator will be obtained with each axillary temperature measurement
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1 hour
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. juni 2012
Primær færdiggørelse (Forventet)
1. oktober 2018
Studieafslutning (Forventet)
1. oktober 2019
Datoer for studieregistrering
Først indsendt
21. maj 2012
Først indsendt, der opfyldte QC-kriterier
21. maj 2012
Først opslået (Skøn)
23. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. februar 2019
Sidst verificeret
1. februar 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UAB Neo 008
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