Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV
23. februar 2015 opdateret af: University of Alabama at Birmingham
Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV
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 V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia.
This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group).
The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed.
Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants.
With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% 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
Tilmelding (Faktiske)
118
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Lusaka, Zambia
- University Teaching Hospital
-
-
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 time 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 less than 2,000g
- Being removed from 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 |
|---|---|
|
Aktiv komparator: Incubator removal-torso bag
Use plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator
|
Upon removal from the 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 and receive a cloth hat.
The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first.
The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
|
|
Placebo komparator: Incubator removal-no plastic bag
Standard bundling practices when removing the infant from the incubator.
No plastic bag used.
|
Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices.
The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Axillary temperature 36.5-37.5 degrees Celsius
Tidsramme: 1-72 hours
|
Temperature taken per axilla for one minute
|
1-72 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Respiratory Distress Syndrome (RDS)
Tidsramme: Op til 4 uger
|
Dokumentation af øget vejrtrækningsarbejde, tilbagetrækninger og behov for ilt, intubation eller overfladeaktivt stof
|
Op til 4 uger
|
|
Pneumothorax
Tidsramme: Op til 4 uger
|
Enten røntgendokumentation af thorax eller klinisk forringelse i overensstemmelse med luftlækage
|
Op til 4 uger
|
|
Sepsis
Tidsramme: Op til 4 uger
|
Kultur bevist eller kulturnegativ klinisk behandlet forløb i overensstemmelse med sepsis
|
Op til 4 uger
|
|
Død
Tidsramme: Op til 4 uger
|
Kardiorespiratorisk svigt
|
Op til 4 uger
|
|
Nekrotiserende enterocolitis eller intestinal perforation
Tidsramme: Op til 4 uger
|
Dokumentation for pneumatose eller intestinal perforation på røntgen- eller behandlingsforløb for klinisk nekrotiserende enterocolitis pr. Bells klassifikationsstadium større end 1.
|
Op til 4 uger
|
|
Blood pressure
Tidsramme: Up to 4 weeks
|
Measure of extremity blood pressure per cuff taken during nursery stay
|
Up to 4 weeks
|
|
Blood glucose
Tidsramme: Up to 4 weeks
|
Measure of blood glucose per laboratory value taken per heel stick
|
Up to 4 weeks
|
|
Seizure
Tidsramme: Up to 4 weeks
|
Seizure activity diagnosed by medical doctor or nurse.
No electoencephalogram will be done.
|
Up to 4 weeks
|
|
Weight gain
Tidsramme: Up to 4 weeks
|
Infant will be weighed daily and rates of weight gain will be calculated
|
Up to 4 weeks
|
|
Bronchopulmonary Dysplasia (BPD)
Tidsramme: 28 days after birth
|
Oxygen requirement at 28 days of life
|
28 days after birth
|
|
Major brain injury
Tidsramme: Up to 4 weeks
|
Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
|
Up to 4 weeks
|
|
Pulmonary hemorrhage
Tidsramme: Up to 4 weeks
|
Blood seen in the endotracheal tube and treated by physician
|
Up to 4 weeks
|
|
Hyperthermia
Tidsramme: Up to 4 weeks
|
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for 1 minute
|
Up to 4 weeks
|
|
Length of time in incubator
Tidsramme: Up to 4 weeks
|
Documentation of length of time spent in incubator and number of times placed in incubator
|
Up to 4 weeks
|
|
Room temperature and humidity
Tidsramme: 1-72 hours
|
A recording of the room temperature and humidity will be obtained with each axillary temperature measurement
|
1-72 hours
|
|
Incubator temperature and humidity
Tidsramme: 1 hour
|
A recording of the air temperature and humidity with the incubator will be obtained with each axillary temperature measurement
|
1 hour
|
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
1. juni 2012
Primær færdiggørelse (Faktiske)
1. august 2014
Studieafslutning (Faktiske)
1. februar 2015
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 (Skøn)
24. februar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. februar 2015
Sidst verificeret
1. februar 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UAB Neo 009
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