Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section (THER5)
11. mai 2013 oppdatert av: PD Dr. Jan Hoecker, University Hospital Schleswig-Holstein
Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section
This study should evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest.
Therefore, the investigators want to investigate the effects of active cutaneous warming of the mothers and babies during intraoperative bonding. The investigators plan to enroll 40 parturients scheduled for elective caesarean section to receive passive insulation or forced-air skin surface warming. The investigators will measure core temperature of the newborns and their mothers. The investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Little is known about the thermoregulatory effects on babies when bonding on the chest of the mother during caesarian section.
The aim of our study is to evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest.
The investigators want to investigate the effects of active cutaneous warming of the mothers and babies during a 20 min intraoperative bonding period.
The investigators plan to enroll 40 parturients scheduled for elective caesarean section under spinal anaesthesia to receive passive insulation or forced-air skin surface warming.
The investigators will measure core temperature of the newborns and their mothers.
The investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Schleswig-Holstein
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Pinneberg, Schleswig-Holstein, Tyskland, 25421
- Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Ikke eldre enn 20 minutter (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- parturients undergoing planned, elective cesarean section under spinal anaesthesia
- mothers classified as American Society of Anaesthesiologists (ASA) status I or II
- written informed consent
Exclusion Criteria:
- mothers younger than 18 years
- mothers classified as American Society of Anaesthesiologists (ASA) status III or higher
- caesarean section planned under general anaesthesia.
any expected problems with the newborn such as:
- gestation date < 36 or > 42 week
- placenta previa, abruption of placenta, green amniotic fluid, amnion infection syndrome or any abnormalities in cardiotocography (CTG)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Control; passive insulation
The mothers will receive passive temperature insulation by a cotton blanket (standard procedure) after start of the spinal anaesthesia for cesarean section.
The newborn will be bonded on the mothers chest under the cotton blanket (also passive insulation without active warming) for 20 min after birth (bonding period).
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Eksperimentell: Active Warming
The mothers will receive active warming by a forced-air warming blanket after start of the spinal anaesthesia for cesarean section.
The newborn will be bonded on the mothers chest under the warming blanket for 20 min after birth (bonding period).
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In the intervention group a forced-air cover (Level 1 Snuggle Warm Upper Body Blanket, Smiths Medicals) will be positioned over the upper body of the patients laying on the operating table just beginning after the spinal block.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Body core temperature of the newborn
Tidsramme: 20 min after birth
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Core temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period)by a rectal temperature probe.
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20 min after birth
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Skin temperature of the newborn
Tidsramme: 20 min after child birth
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Skin temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period) at chest, arm, thigh, and calf.
Mean-skin temperature will be calculated from these measurements.
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20 min after child birth
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Shivering incidence of the mothers
Tidsramme: 20 min after child birth
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Shivering of the mothers will be graded by a four-point scale.
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20 min after child birth
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Thermal comfort of the mothers
Tidsramme: 20 min after child birth
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Thermal comfort of the mother will be evaluated with a 100-mm visual analogue scale.
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20 min after child birth
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Mean arterial blood pressure of the mothers.
Tidsramme: 20 min after child birth
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Mean arterial blood pressure of the mothers will be assessed by non-invasive measurement.
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20 min after child birth
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Core temperature of the mothers
Tidsramme: 20 min after child birth
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Core temperature will be measured by a sublingual temperature probe.
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20 min after child birth
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Skin temperature of the mothers.
Tidsramme: 20 min after child birth
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Skin temperature of the mothers will be assessed at the chest.
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20 min after child birth
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Berthold Bein, M.D., University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2013
Primær fullføring (Faktiske)
1. april 2013
Studiet fullført (Faktiske)
1. april 2013
Datoer for studieregistrering
Først innsendt
12. februar 2013
Først innsendt som oppfylte QC-kriteriene
14. februar 2013
Først lagt ut (Anslag)
15. februar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. mai 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2013
Sist bekreftet
1. mai 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- THER-5
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