Thermoregulation ImpairmentTHER5NCT01793558
Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section
A study testing Forced-air warming in people with Thermoregulation Impairment and Hypothermia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 20 minutesHealthy volunteers can take part
- Conditions the study is for
- Thermoregulation Impairment, Hypothermia, Postoperative Shivering
- What is being tested?
- Forced-air warming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- parturients undergoing planned, elective cesarean section under spinal anaesthesia
- mothers classified as American Society of Anaesthesiologists (ASA) status I or II
- written informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
Pinneberg, Schleswig-Holstein, 25421
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Forced-air warming
- Keywords
- Thermoregulation Impairment, hypothermia, Postoperative shivering, cesarean section, newborn
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced-air warmingProcedure or surgery
Also called Level 1 Snuggle Warm Upper Body Blanket, Forced-air warming blower
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.
| Study group | Role | What they receive |
|---|---|---|
| Control; passive insulation | No intervention | 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). |
| Active Warming | Experimental | 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). Receives: Procedure: Forced-air warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body core temperature of the newborn
Core temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period)by a rectal temperature probe.
Measured: 20 min after birth
Secondary outcomes (1)
Skin temperature of the newborn
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.
Measured: 20 min after child birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermoregulation ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Jan Hoecker, University Hospital Schleswig-Holstein
- Investigators
- Berthold Bein, M.D., Study chair, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793558
- Sponsor's protocol ID
- THER-5
- Acronym
- THER5
- Status last verified
- May 2013
- First submitted
- 12 Feb 2013
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section
- ClinicalTrials.gov ID
- NCT01793558
- Acronym / sponsor ID
- THER5 / THER-5
- Keywords
- Thermoregulation Impairment, hypothermia, Postoperative shivering, cesarean section, newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control; passive insulation | No intervention | –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). |
| Active Warming | Experimental | Procedure: Forced-air warmingThe 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). |
Who may qualify
- Ages
- Up to 20 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- parturients undergoing planned, elective cesarean section under spinal anaesthesia
- mothers classified as American Society of Anaesthesiologists (ASA) status I or II
- written informed consent
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced-air warmingAlso: Level 1 Snuggle Warm Upper Body Blanket, Forced-air warming blowerIn 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. | Procedure or surgery | Active Warming |
Primary outcome
Body core temperature of the newborn
Time frame: 20 min after birth
Core temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period)by a rectal temperature probe.
1 secondary outcome
Skin temperature of the newborn
Time frame: 20 min after child birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Bein, M.D. study chair
University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced-air warming in people with Thermoregulation Impairment and Hypothermia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body core temperature of the newborn (time frame: 20 min after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013.