HypothermiaNCT00904228
Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room
A study testing placement of plastic cap during delivery room stabilization and placement of routine cap during delivery room stabilization in people with Hypothermia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this research project is to ascertain the effectiveness of plastic head covering in prevention of hypothermia. Hypothermia is defined by body temperature <36.5º Celsius by the World Health Organization. Read more about this study
- Who is it for?
- Ages Up to 1 hourHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- placement of plastic cap during delivery room stabilization and placement of routine cap during delivery room stabilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2010
- 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 1 hour
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants with less than 33 week gestational age by obstetrical dating
- Infants delivered in Parkland Memorial Hospital Labor and Delivery areas
- Infant whose delivery was attended by the Parkland Neonatal Resuscitation Team
- Infant whos is viable
Who cannot join
- Infant who has 33 week gestational age or greater by obstetrical dating
- Infant who is deemed non-viable
- Infant who did not have the Parkland Neonatal Resuscitation Team present at time of birth
- Infant with congenital anomaly which precludes measurement of rectal temperature (such as anal atresia or imperforate anus)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Plastic Lined Hats for Prevention of Hypothermia in Premature Newborns in the Delivery Room
The purpose of this research project is to ascertain the effectiveness of plastic head covering in prevention of hypothermia. Hypothermia is defined by body temperature <36.5º Celsius by the World Health Organization. The surface area of the head is about 20% of total body surface of a newborn infant and is a major source of heat loss. The objective is to compare rectal temperature upon admission to the neonatal intensive care between preterm neonates who had stockinet head covering and those who had plastic-lined stockinet head covering placed in the delivery room. The investigators aim to demonstrate that plastic-lined head covering is more effective than stockinet head covering alone in maintaining body temperature.
Read the detailed description
A prospective randomized control trial will be conducted in Parkland Memorial Hospital (PMH) neonatal intensive care unit (NICU) Dallas, Texas. Consent will not be obtained since: placement of plastic and/or stockinet head covering on the neonate is part of routine resuscitation care at PMH and by Neonatal Resuscitation Program (NRP) minimal risk to the preterm neonate is involved, post-delivery consent will be of little value since intervention only last ~24minutes, and obtaining informed consent from a mother who has labor pains or is on pain medication may be difficult.
Randomization of the neonates will be carried out in the delivery room by opening a sealed, opaque envelope just prior to birth. Qualified preterm newborns will be stratified into 2 OB EGA groups: (≤28weeks obstetrical(OB)estimated gestational age (EGA) and 29-32weeks OB EGA. In each stratified group, the newborns will be further randomized to control arm (stockinet head covering) or the intervention arm (plastic-lined head covering). Each arm of the study will have a sample size of 65, allowing for 130 infants in each OB EGA stratified group and for a sample size total of 260. Treatment versus control will be assigned by blocks of 8 by using a random permutation table. The assignment will be sealed in an opaque envelope by a non-participant person of the research.
The PMH high-risk resuscitation (RESUS) team attends all deliveries of infants ≤32 weeks OB EGA. The RESUS team is comprised of a resuscitation nurse, a respiratory therapist, and a practitioner. Neonatology fellow and/or attending may also attend these deliveries.
The use of warming aids by the RESUS team is standardized in the following manner: Randomization envelope will be opened. All infants will be taken from the obstetrician by the practitioner to an Ohio radiant warmer that has been pre-warmed to 100% capacity prior to the delivery of the infant. A food-grade storage (polyethylene) bag (will be referred as "poncho") will be used on all infants with the EGA of 32 weeks or less OB EGA to decrease evaporative and convective heat loss. The poncho will be placed by cutting a hole at the closed end of the bag for the purposes of inserting the head through it. The infants will not be dried except for the face as recommended by NRP. All infants that are ≤28weeks OB EGA will have a transwarmer mattress gel pad activated and placed on the radiant warmer during resuscitation and during transport as per PMH NICU and NRP standard practice. The appropriate head covering will then be placed to the level of the forehead on the infant as per randomization assignment. If access to the infant's umbilical cord is needed, a hole will be cut at the appropriate location. All infants will be transported in a dedicated isolette for resuscitation that has been prewarmed to 38ºC. The warming aids will be in place until the infant's arrival in the NICU.
The RESUS team will gather the following data in the delivery room: environmental temperature of the delivery room, rectal temperature immediately after delivery, annotation of warming aids implemented. The RESUS team also cares for the infant in the first 4 hours of life. Initial vital signs (heart rate, respiratory rate, and blood pressure), temperature, need of ventilation, need of intervention will be recorded by the RESUS team. After 4 hours the care will be assumed by the primary NICU team as per our standard practice.
Once the admission rectal temperature is taken, the head coverings will be removed and the infant will no longer be actively enrolled in the research. The rest of the data will be gathered through the Neonatal Resuscitation Database and Parkland NICU Morbidity and Mortality Database.
The rationale of this study is that no randomized control trial has been done to demonstrate the effectiveness of placement of plastic-lined head covering versus stockinet head covering. It would seem logical that if measures are taken to decrease heat loss from the head, these measures would improve temperature stability and avoid hypothermia in the premature neonate.
- Conditions
- Hypothermia
- Being tested
- placement of plastic cap during delivery room stabilization, placement of routine cap during delivery room stabilization
- Keywords
- hypothermia, euthermia, hyperthermia, mortality, morbidity, sepsis, bronchopulmonary dysplasia, intraventricular hemorrhage, ventilator days
- Medical subject headings
- Hypothermia, Hyperthermia, Sepsis, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement of plastic cap during delivery room stabilizationOther
placement of plastic cap during delivery room stabilization
placement of routine cap during delivery room stabilizationOther
| Study group | Role | What they receive |
|---|---|---|
| Plastic Cap | Experimental | Plastic lined stockinet cap (polyethylene bag) Receives: Other: placement of plastic cap during delivery room stabilization |
| Stockinet Cap | Active comparator | Usual practice Receives: Other: placement of routine cap during delivery room stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothermia
admission rectal temperature <36.5C
Measured: 1 hour
Secondary outcomes (7)
Mortality
Death before hospital discharge
Measured: 1 year
Infection
+ blood cultures
Measured: 1 year
Necrotizing enterocolitis
Bell Bell's criteria
Measured: 1 year
Intraventricular Hemorrhage
Any grade
Measured: 1 year
Bronchopulmonary Dysplasia
Oxygen requirement at 36 weeks corrected age (NIH definition)
Measured: 1 year
Days on Ventilator
Invasive ventilation
Measured: 1 year
Length of hospital stay
days of initial hospitalization after birth
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 posted19 May 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myra Wyckoff, University of Texas Southwestern Medical Center
- Investigators
- Lilian T StJohn, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904228
- Sponsor's protocol ID
- 052008-049
- Status last verified
- Apr 2019
- First submitted
- 27 Feb 2009
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Plastic Lined Hats for Prevention of Hypothermia in Premature Newborns in the Delivery Room
- ClinicalTrials.gov ID
- NCT00904228
- Acronym / sponsor ID
- 052008-049
- Conditions
- Hypothermia
- Keywords
- hypothermia, euthermia, hyperthermia, mortality, morbidity, sepsis, bronchopulmonary dysplasia, intraventricular hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 May 2009 (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.
The purpose of this research project is to ascertain the effectiveness of plastic head covering in prevention of hypothermia. Hypothermia is defined by body temperature <36.5º Celsius by the World Health Organization. The surface area of the head is about 20% of total body surface of a newborn infant and is a major source of heat loss. The objective is to compare rectal temperature upon admission to the neonatal intensive care between preterm neonates who had stockinet head covering and those who had plastic-lined stockinet head covering placed in the delivery room. The investigators aim to demonstrate that plastic-lined head covering is more effective than stockinet head covering alone in maintaining body temperature.
Detailed description
A prospective randomized control trial will be conducted in Parkland Memorial Hospital (PMH) neonatal intensive care unit (NICU) Dallas, Texas. Consent will not be obtained since: placement of plastic and/or stockinet head covering on the neonate is part of routine resuscitation care at PMH and by Neonatal Resuscitation Program (NRP) minimal risk to the preterm neonate is involved, post-delivery consent will be of little value since intervention only last ~24minutes, and obtaining informed consent from a mother who has labor pains or is on pain medication may be difficult.
Randomization of the neonates will be carried out in the delivery room by opening a sealed, opaque envelope just prior to birth. Qualified preterm newborns will be stratified into 2 OB EGA groups: (≤28weeks obstetrical(OB)estimated gestational age (EGA) and 29-32weeks OB EGA. In each stratified group, the newborns will be further randomized to control arm (stockinet head covering) or the intervention arm (plastic-lined head covering). Each arm of the study will have a sample size of 65, allowing for 130 infants in each OB EGA stratified group and for a sample size total of 260. Treatment versus control will be assigned by blocks of 8 by using a random permutation table. The assignment will be sealed in an opaque envelope by a non-participant person of the research.
The PMH high-risk resuscitation (RESUS) team attends all deliveries of infants ≤32 weeks OB EGA. The RESUS team is comprised of a resuscitation nurse, a respiratory therapist, and a practitioner. Neonatology fellow and/or attending may also attend these deliveries.
The use of warming aids by the RESUS team is standardized in the following manner: Randomization envelope will be opened. All infants will be taken from the obstetrician by the practitioner to an Ohio radiant warmer that has been pre-warmed to 100% capacity prior to the delivery of the infant. A food-grade storage (polyethylene) bag (will be referred as "poncho") will be used on all infants with the EGA of 32 weeks or less OB EGA to decrease evaporative and convective heat loss. The poncho will be placed by cutting a hole at the closed end of the bag for the purposes of inserting the head through it. The infants will not be dried except for the face as recommended by NRP. All infants that are ≤28weeks OB EGA will have a transwarmer mattress gel pad activated and placed on the radiant warmer during resuscitation and during transport as per PMH NICU and NRP standard practice. The appropriate head covering will then be placed to the level of the forehead on the infant as per randomization assignment. If access to the infant's umbilical cord is needed, a hole will be cut at the appropriate location. All infants will be transported in a dedicated isolette for resuscitation that has been prewarmed to 38ºC. The warming aids will be in place until the infant's arrival in the NICU.
The RESUS team will gather the following data in the delivery room: environmental temperature of the delivery room, rectal temperature immediately after delivery, annotation of warming aids implemented. The RESUS team also cares for the infant in the first 4 hours of life. Initial vital signs (heart rate, respiratory rate, and blood pressure), temperature, need of ventilation, need of intervention will be recorded by the RESUS team. After 4 hours the care will be assumed by the primary NICU team as per our standard practice.
Once the admission rectal temperature is taken, the head coverings will be removed and the infant will no longer be actively enrolled in the research. The rest of the data will be gathered through the Neonatal Resuscitation Database and Parkland NICU Morbidity and Mortality Database.
The rationale of this study is that no randomized control trial has been done to demonstrate the effectiveness of placement of plastic-lined head covering versus stockinet head covering. It would seem logical that if measures are taken to decrease heat loss from the head, these measures would improve temperature stability and avoid hypothermia in the premature neonate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plastic Cap | Experimental | Other: placement of plastic cap during delivery room stabilizationPlastic lined stockinet cap (polyethylene bag) |
| Stockinet Cap | Active comparator | Other: placement of routine cap during delivery room stabilizationUsual practice |
Who may qualify
- Ages
- Up to 1 hour
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants with less than 33 week gestational age by obstetrical dating
- Infants delivered in Parkland Memorial Hospital Labor and Delivery areas
- Infant whose delivery was attended by the Parkland Neonatal Resuscitation Team
- Infant whos is viable
Key exclusion criteria (4 listed)
- Infant who has 33 week gestational age or greater by obstetrical dating
- Infant who is deemed non-viable
- Infant who did not have the Parkland Neonatal Resuscitation Team present at time of birth
- Infant with congenital anomaly which precludes measurement of rectal temperature (such as anal atresia or imperforate anus)
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 |
|---|---|---|
| placement of plastic cap during delivery room stabilizationplacement of plastic cap during delivery room stabilization | Other | Plastic Cap |
| placement of routine cap during delivery room stabilization | Other | Stockinet Cap |
Primary outcome
Hypothermia
Time frame: 1 hour
admission rectal temperature <36.5C
7 secondary outcomes
Mortality
Time frame: 1 year
Infection
Time frame: 1 year
Necrotizing enterocolitis
Time frame: 1 year
Intraventricular Hemorrhage
Time frame: 1 year
Bronchopulmonary Dysplasia
Time frame: 1 year
Days on Ventilator
Time frame: 1 year
Length of hospital stay
Time frame: 1 year
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 25 Apr 2019.
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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.
Lilian T StJohn, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing placement of plastic cap during delivery room stabilization and placement of routine cap during delivery room stabilization in people with Hypothermia, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 4 inclusion and 4 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 25 Apr 2019. 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 United States. 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?
Hypothermia (time frame: 1 hour). 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 25 Apr 2019.