Hypothermia, NewbornNCT05505903
Influence of Duration Since Birth Until Admission to Well-baby Nursery on Neonatal Temperature at Admission
An observational study of Hypothermia, Newborn, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth. Read more about this study
- Who is it for?
- Ages Up to 2 hoursHealthy volunteers can take part
- Conditions the study is for
- Hypothermia, Newborn
- What is being tested?
- Temerature measurement
- How many people
- 2,412 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2022to 28 Feb 2023
- Phase
- Observational
- 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 2 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants born at Hillel Yaffe meducal center
Who may be able to join
- all newborn infants
Who cannot join
- infants born after less than 35 complete gestational weeks
Trial locations and contacts
1 site in 1 country.
Israel1 site
Neonatal intensive care unit, Hillel Yaffe medical center
Hadera, 38100
About this study
The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.
The investigators will divide the newborn infants to three groups: infants born vaginally, infants born by regular Cesarean section, and infants born by friendly Cesarean section, and compare the groups.
Read the detailed description
Introduction Friendly Cesarean section mimics normal vaginal delivery as the newborn is put on mother's chest immediately after delivery and cutting the umbilical cord, and the mother even breastfeeds the newborn infant, if she wishes to. Friendly Cesarean section is offered to the mother if there are no contraindications, such as general anesthesia, fetal distress, or prematurity. Skin to skin contacts lasts for several minutes, as long as the mothers wish to, and depend on mothers' medical state, and newborns' medical state.
In friendly Cesarean section, the skin to skin contact technique includes putting the newborn on mother's chest, and covering them both by a blanket. Yet, during Cesarean section the mother is covered by a thin paper-like sterile sheet, and as the temperature in operating room is low, her skin cools gradually from the spinal anesthesia until actually delivering the newborn infant. So, although the newborn infant is put on the mother's chest and covered by a blanket, there is a possibility for it to develop hypothermia.
Literature about this issue is rare, so the investigators conducted a study to check this possibility.
Methods In Hillel Yaffe medical center nurses measure infants temperature on admission to well-baby nursery (WBN) or neonatal intensive care unit (NICU). Admission is not always performed on arrival, due to other nurse-tasks, such as other newborn infants treatment, or breastfeeding education.
The most measureable piece of data that characterize friendly Cesarean section is the longer time interval from the birth until arrival to WBN or NICU.
Inclusion criteria: infants born within the time study interval. Exclusion criteria: infants born at less than complete 35 gestational weeks, since there is no for offer friendly Cesarean section for these births.
The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.
The investigators will divide the newborn infants to three groups: infants born vaginally, infants born by regular Cesarean section, and infants born by friendly Cesarean section, and compare the groups.
- Conditions
- Hypothermia, Newborn
- Being tested
- Temerature measurement
- Keywords
- hypothermia, friendly Cesarean section
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temerature measurementDiagnostic test
Temerature measurement on admission to WBN or NICU
| Study group | Role | What they receive |
|---|---|---|
| Vaginal delivery | Newborn Infants born by vaginal delivery. Receives: Diagnostic Test: Temerature measurement | |
| Regular Cesarean section | Newborn infants born by regular Cesarean section Receives: Diagnostic Test: Temerature measurement | |
| Friendly Cesarean section | Newborn infants born by friendly Cesarean section Receives: Diagnostic Test: Temerature measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
The temperature upon admission to WBN or NICU
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Mar 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia, NewbornStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erez Nadir, MD, Hillel Yaffe Medical Center
- Investigators
- Erez Nadir, MD, Study chair, Hille Yaffe medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505903
- Sponsor's protocol ID
- 0032-22-HYMC-IL
- Status last verified
- Mar 2023
- First submitted
- 4 Oct 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Duration Since Birth Until Admission to Well-baby Nursery on Neonatal Temperature at Admission
- ClinicalTrials.gov ID
- NCT05505903
- Acronym / sponsor ID
- 0032-22-HYMC-IL
- Conditions
- Hypothermia, Newborn
- Keywords
- hypothermia, friendly Cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,412 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 18 Aug 2022 (actual)
- 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.
The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.
The investigators will divide the newborn infants to three groups: infants born vaginally, infants born by regular Cesarean section, and infants born by friendly Cesarean section, and compare the groups.
Detailed description
Introduction Friendly Cesarean section mimics normal vaginal delivery as the newborn is put on mother's chest immediately after delivery and cutting the umbilical cord, and the mother even breastfeeds the newborn infant, if she wishes to. Friendly Cesarean section is offered to the mother if there are no contraindications, such as general anesthesia, fetal distress, or prematurity. Skin to skin contacts lasts for several minutes, as long as the mothers wish to, and depend on mothers' medical state, and newborns' medical state.
In friendly Cesarean section, the skin to skin contact technique includes putting the newborn on mother's chest, and covering them both by a blanket. Yet, during Cesarean section the mother is covered by a thin paper-like sterile sheet, and as the temperature in operating room is low, her skin cools gradually from the spinal anesthesia until actually delivering the newborn infant. So, although the newborn infant is put on the mother's chest and covered by a blanket, there is a possibility for it to develop hypothermia.
Literature about this issue is rare, so the investigators conducted a study to check this possibility.
Methods In Hillel Yaffe medical center nurses measure infants temperature on admission to well-baby nursery (WBN) or neonatal intensive care unit (NICU). Admission is not always performed on arrival, due to other nurse-tasks, such as other newborn infants treatment, or breastfeeding education.
The most measureable piece of data that characterize friendly Cesarean section is the longer time interval from the birth until arrival to WBN or NICU.
Inclusion criteria: infants born within the time study interval. Exclusion criteria: infants born at less than complete 35 gestational weeks, since there is no for offer friendly Cesarean section for these births.
The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.
The investigators will divide the newborn infants to three groups: infants born vaginally, infants born by regular Cesarean section, and infants born by friendly Cesarean section, and compare the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaginal delivery | – | Diagnostic Test: Temerature measurementNewborn Infants born by vaginal delivery. |
| Regular Cesarean section | – | Diagnostic Test: Temerature measurementNewborn infants born by regular Cesarean section |
| Friendly Cesarean section | – | Diagnostic Test: Temerature measurementNewborn infants born by friendly Cesarean section |
Who may qualify
- Ages
- Up to 2 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants born at Hillel Yaffe meducal center
Key inclusion criteria (1 listed)
- all newborn infants
Key exclusion criteria (1 listed)
- infants born after less than 35 complete gestational weeks
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 |
|---|---|---|
| Temerature measurementTemerature measurement on admission to WBN or NICU | Diagnostic test | Friendly Cesarean section, Regular Cesarean section, Vaginal delivery |
Primary outcome
Temperature
Time frame: 1 year
The temperature upon admission to WBN or NICU
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 13 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Erez Nadir, MD study chair
Hille Yaffe medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia, Newborn, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 13 Mar 2023. 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 Israel. 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?
Temperature (time frame: 1 year). 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 13 Mar 2023.