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Neonatal HypothermiaNeoHypNCT03316716

Active Warming Versus Non Active Warming During Caesarean Section for Preventing Neonatal Hypothermia

A study testing active warming in people with Neonatal Hypothermia, run by Aliona Vilinsky-Redmond at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Peri-operative warming is well established for general operations, but there is limited literature on the active warming of pregnant women undergoing caesarean section (CS). Specifically, there is a lack of evidence on the effect, if any, of actively warming mothers on the new-born's temperature and general wellbeing. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Neonatal Hypothermia
What is being tested?
active warming
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteIreland
Study dates
24 Jan 2018to 31 May 2018
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 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • In order for women and their new-borns to be eligible to participate in the study they should be;
  • Aged 18 years or over
  • Able to provide informed consent for themselves and their babies
  • Who have a singleton pregnancy between 37+0 and 41+6 weeks gestation
  • Whose foetus/new-born is alive/born alive, and has no risk factors such as congenital or cardiovascular anomalies (see Appendix 2, TSRF)
  • Who receive spinal or combined spinal anaesthesia for their caesarean section
  • Have an elective CS
  • Who are willing and able to perform skin-to-skin contact

Who cannot join

  • Women will be excluded from this study if they;
  • Have pyrexia (> 37.5C on admission to ward)
  • Have a maternal medical disease (ie. Spinal abnormalities, coagulation abnormalities, maternal serology positive, congestive heart failure, severe renal function impairment)
  • Have general anaesthesia
  • Have a baby who has a congenital anomaly (ie. Spina bifida, anencephaly, hydrocephaly, cardiovascular anomalies, anomalies of nervous system, defects of anterior abdominal wall)
  • Have a baby who has abnormal Doppler artery velocimetry
  • Have a stillbirth baby
  • Have a recent USS estimating the fetal weight less than 2000g

Trial locations and contacts

1 site in 1 country.

Ireland1 site
  • Rotunda Hospital

    Dublin, Dublin 1

Other trials in Ireland

About this study

Official title: Peri-operative Active Warming Versus no Peri-operative Active Warming During Caesarean Section for Preventing Neonatal Hypothermia in Women Performing Skin-to-skin Care: A Randomized Controlled Trial

Peri-operative warming is well established for general operations, but there is limited literature on the active warming of pregnant women undergoing caesarean section (CS). Specifically, there is a lack of evidence on the effect, if any, of actively warming mothers on the new-born's temperature and general wellbeing. The two active warming methods recommended by NICE are the use of forced-air warming and fluid warmers.

Women's temperature tends to fall below the normal level (36.0oC to 37.5oC) during caesarean section if they have not been actively warmed during their operation (peri-operative). Peri-operative hypothermia may increase the morbidities experienced by women after caesarean section. While shivering is the most common postoperative incident, hypothermia may delay wound healing or increase the risk of wound infection, and can increase the risk of haemorrhage.

Read more

Neonatal hypothermia has a direct effect on the baby's cardiopulmonary, vascular system and central nervous system and increases the risks of mortality and morbidity. Specifically, neonatal hypothermia can lead to respiratory difficulties and apnoea, hypoxemia, carbon dioxide retention, metabolic acidosis, hypoglycaemia and decreased oxygen delivery to the tissues.

The absence of research and evidence on the effects of actively warming women undergoing caesarean section at term gestation on the temperature of new-borns during SSC means that further research is required.

Read the detailed description

Peri-operative active warming is the practice of warming patients who undergo an operation with the use of one or more warming devices. Active warming can be initiated before, during and/or after an operation and its main purpose is to prevent and/or manage hypothermia in patients. Commonly used warming devices include: forced-air warming, fluid warmers, heating gel pads, water mattresses and electric blankets.

Peri-operative active warming has been researched over the past 30 years, with more sophisticated methods of active warming being introduced in recent years. Regardless of their complexity, these devices are used in order to prevent inadvertent perioperative hypothermia (IPH) and its complications in patients who undergo an operation. Complications of IPH include: thermal discomfort (including shivering), increased intra-operative blood loss, increased risk of wound infection, cardiac morbid events and increased length of stay in recovery room and in the hospital.

Although peri-operative warming is well established for general operations, there is a dearth of literature regarding active warming of pregnant women undergoing caesarean section (CS). The National Institute of Health and Care Excellence (NICE) developed guidelines for managing IPH for adults undertaking various general operations, however pregnant women and children/infants were excluded from these guidelines due to lack of evidence supporting or rejecting the use of peri-operative active warming for this population. The two active warming methods recommended by NICE include the use of forced-air warming and fluid warmers. Specifically all patients should be actively warmed with a forced-air warming device before/during their operation if their temperature is below 36°C and every patient should receive warmed IV fluids (via an IV fluid warmer) for volumes ≥500 mls of IV fluids. The patient's temperatures should be measured every 30 minutes from the time of their anaesthesia until their discharge to the ward.

An additional factor that complicates the decision of applying, or not, an active warming to pregnant women during a CS is the effect of active warming on new-borns during/after birth. This factor becomes even more relevant when skin-to-skin contact (SSC), between mothers and their new-borns, is initiated immediately after a CS. Specifically, there is a lack of research evidence on the effect, if any, of active warming on the new-born's temperature and general wellbeing. Three unpublished audits undertaken in the theatre department of a large maternity hospital in Dublin (between 2012 and 2014), have shown an increased number of hypothermic mothers and new-borns during and after CS. The hospital has a general practice of not actively warming pregnant women before/during their CS, and women at low risk for complications, usually perform SSC with their infants within minutes of birth. The more recent of these three audits (2014) showed that 86% (n=33) of women became hypothermic peri-operatively (defined as a core temperature below 36°C, while 35% (n=14) of the new-borns became mildly hypothermic after birth (defined as a core temperature below 36.5°C, after undergoing SSC, despite complying with the hospital guidelines.

SSC is a widely researched technique, in which a naked new-born (wearing only a nappy and a hat) is positioned on its mother's bare chest, covered with warm towels and a blanket. SSC has multiple advantages for both mothers and their new-borns. SSC is a usual practice within Rotunda Hospital, for babies born either vaginally or via CS. Although this technique is well established after vaginal birth, there is a great demand and attempts to establish it in mother-infant dyads after birth by a CS. A potential concern arising from this practice, however, is that new-borns, born by a CS, are more prone to losing their temperature and become hypothermic after a CS, compared with those born via normal birth. A risk factor is that if the mothers core temperature drops during the CS, leading to an even lower skin temperature, then the risk of a drop in the temperature of the new-born (via conduction) is increased by placing the naked baby for SSC on a mother whose temperature is suboptimal.

When either the mother or the new-born become hypothermic after a CS, there is a higher chance that both will be separated in order to be heated, often in different rooms. When this separation takes place, SSC is interrupted, early breastfeeding is delayed and the stress levels of the mother will increase as she would be concerned about her new-born's wellbeing. Additionally, babies who become hypothermic once, or have reoccurring cases of hypothermia, after birth are more likely to have invasive procedures such as blood sugar monitoring, rectal temperature measurements and blood checks for microbiological investigation and prophylactic administration of IV antibiotics (as per hospital's guidelines). These invasive procedures could be prevented especially in low risk babies (i.e. term babies with weight within the normal limits, or babies whose mothers are not diabetic) by keeping them warm and providing early feeding and SSC.

These obstacles could potentially be eliminated with the use of peri-operative active warming. The effects of peri-operative active warming in pregnant women remains inadequately researched, with even fewer studies evaluating the effects of peri-operative active warming on new-borns who are having SSC.

Being tested
active warming
Keywords
caesarean section, neonatal hypothermia, maternal hypothermia, active warming, skin-to-skin contact

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • active warmingProcedure or surgery

    Women randomised to the intervention group will be administrated warm IV fluids (39°C) consisting of Hartman's solution with the use of the theatre's Hotline™ device. The Hotline™ device is set to 39°C in which the Hartman's solution bags will be infused to the women peri-operatively.

Study groups in NCT03316716
Study groupRoleWhat they receive
Control GroupNo interventionWomen randomised to the control group will receive the hospital's current standard of care which is the peri-operative administration of room-temperature (25°C) IV fluids (Hartman's solution) started before the insertion of regional anaesthesia and continued until the transfer of the woman to the postnatal ward.
active warming groupExperimentalWomen randomised in the intervention group will recieve warm IV fluids. The IV fluids (Hartman's solution) will be warmed to 39°C with the use of Hotline™ device.
Receives: Procedure: active warming

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal hypothermia

    Neonatal hypothermia is defined as temperature < 36.5C

    Measured: approximately 50 minutes after delivery

Secondary outcomes (13)
  1. Maternal Hypothermia

    Maternal hypothermia is defined as temperature < 36C

    Measured: approximately 10 minutes before delivery

  2. Maternal Hypothermia

    Maternal hypothermia is defined as temperature < 36C

    Measured: approximately 30 minutes after delivery

  3. Maternal Hypothermia

    Maternal hypothermia is defined as temperature < 36C

    Measured: approximately 50 minutes after delivery

  4. Maternal core temperatures

    Maternal core temperatures measured on 3 different occasions

    Measured: approximately 10 minutes before delivery

  5. Maternal core temperatures

    Maternal core temperatures measured on 3 different occasions

    Measured: approximately 30 minutes after delivery

  6. Maternal core temperatures

    Maternal core temperatures measured on 3 different occasions

    Measured: approximately 50 minutes after delivery

  7. Neonatal core temperatures

    Neonatal core temperatures measured on 2 different occasions

    Measured: approximately 20 minutes after delivery

  8. Neonatal core temperatures

    Neonatal core temperatures measured on 2 different occasions

    Measured: approximately 50 minutes after delivery

  9. Maternal thermal comfort

    Maternal thermal comfort measured using a 1-5 scale ranging from cold, cool, neutral, warm and hot

    Measured: approximately 30 minutes after delivery

  10. Shivering

    Shivering (yes/no)

    Measured: approximately 30 minutes after delivery

  11. additional maternal warming

    Use of additional warming of mothers (Bair Hugger™)

    Measured: approximately 30 minutes after delivery

  12. additional new-born warming

    Use of additional warming of new-born (incubator)

    Measured: approximately 20 minutes after delivery

  13. Occurrence of Adverse Events

    Occurrence of Adverse Events during the trial

    Measured: From date of randomization until the date of first documented progression , assessed up to 2 hours post operation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2017
  2. Study start24 Jan 2018
  3. Primary completion31 May 2018
  4. Study completion31 May 2018

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03316716
Sponsor's protocol ID
RotundaH
Acronym
NeoHyp
Status last verified
Jun 2018
First submitted
2 Oct 2017
Last updated
15 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Munday J, Hines S, Wallace K, Chang AM, Gibbons K, Yates P. A systematic review of the effectiveness of warming interventions for women undergoing cesarean section. Worldviews Evid Based Nurs. 2014 Dec;11(6):383-93. doi: 10.1111/wvn.12067. Epub 2014 Sep 30.

    PubMed 25269994
  • NICE (2008) The Management of Inadvertent Perioperative Hypothermia in Adults. Retrieved from http://www.ncbi.nlm.nih.gov/books/NBK53797/ on 18/8/2016.

  • Vilinsky A., Sheridan A. & Nugent L.E. (2016) Preventing peri-operative maternal and neonatal hypothermia after skin-to-skin contact. Journal of Neonatal Nursing 22(4), 163-170.

  • WHO (1997) Thermal protection of the newborn: a practical guide. , Maternal and Newborn Health/Safe Motherhood Unit, Division of Reproductive Health

  • Knobel R, Holditch-Davis D. Thermoregulation and heat loss prevention after birth and during neonatal intensive-care unit stabilization of extremely low-birthweight infants. Adv Neonatal Care. 2010 Oct;10(5 Suppl):S7-14. doi: 10.1097/ANC.0b013e3181ef7de2.

    PubMed 20838082
  • Kumar V, Shearer JC, Kumar A, Darmstadt GL. Neonatal hypothermia in low resource settings: a review. J Perinatol. 2009 Jun;29(6):401-12. doi: 10.1038/jp.2008.233. Epub 2009 Jan 22.

    PubMed 19158799
  • Lunze K, Bloom DE, Jamison DT, Hamer DH. The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival. BMC Med. 2013 Jan 31;11:24. doi: 10.1186/1741-7015-11-24.

    PubMed 23369256
  • Smith J. (2014) Methods and Devices of Temperature Measurement in the Neonate: A Narrative Review and Practice Recommendations. Newborn and Infant Nursing Reviews 14(2), 64-71.

  • Vilinsky A. & Sheridan A. (2014) Hypothermia in the newborn: An exploration of its cause, effect and prevention. British Journal of Midwifery 22(8), 557-562 556p.

Questions about this trial

What is this clinical trial studying?

A study testing active warming in people with Neonatal Hypothermia, run by Aliona Vilinsky-Redmond at 1 site in Ireland.

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 8 inclusion and 8 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 15 Jun 2018. 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 Ireland. 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?

Neonatal hypothermia (time frame: approximately 50 minutes after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03316716, which also lists 9 linked publications.

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 15 Jun 2018.

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