AzTrials
AzTrials

Neonatal HypothermiaNCT06003140

Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria

A study testing Celsi Warmer in people with Neonatal Hypothermia, run by William Marsh Rice University at 1 site in Nigeria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The prevalence of hypothermia across low-resource settings is high, especially in countries with high neonatal mortality rates. If left untreated, hypothermia can additionally result in a significant comorbidity, and has been linked to a reduction in the effectiveness of treatment for other newborn conditions. Read more about this study

Who is it for?
Ages 1 day to 28 days
Conditions the study is for
Neonatal Hypothermia
What is being tested?
Celsi Warmer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteNigeria
Study dates
15 Aug 2023to 21 Oct 2024
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 1 day to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Any neonate who:
  • Is currently being treated at study location,
  • Is an inborn admission to the neonatal ward,
  • Whose parents or guardians provided informed consent,
  • Whose parents or guardians providing informed consent are 18 years old or older,
  • Has a current weight of greater than or equal to 1.0 kg and less than or equal to 4.0 kg,
Show all 9Show fewer
  • Has been identified as in need of thermal care defined as having a moderate to severe hypothermic temperature (32.0-36.0 °C) as the last temperature recorded in hospital chart, or during recruitment procedures; and
  • is unable to be enrolled in Kangaroo Mother Care (KMC) for reasons including, but not limited to: a. Mother/guardian unable or unavailable to provide KMC b. Under observation in the Neonatal Intensive Care Unit (NICU) before transfer to KMC c. No space in KMC d. Clinician's discretion;
  • May be receiving other medical treatments, including but not limited to, Continuous Positive Airway Pressure (CPAP), oxygen therapy, intravenous (IV) fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia.

Who cannot join

  • Requires mechanical ventilation;
  • Is deemed in need of intensive care by the hospital staff who is providing care, including but not limited to: a. neonates with severe anemia and/or any suspected hematological disorders, and/or b. Neonates with obvious congenital anomalies, and/or c. neonates suspected with hypo/hyperthyroidism or any hormonal disorders;
  • has been diagnosed with birth asphyxia;
  • Presents a condition that precludes the use of the temperature sensor and/or abdominal belt including but not limited to, known umbilical cord infection, known skin infection;
  • Whose clinician presents concerns about their participation;
  • Is receiving treatment that participation in the study would interfere with (e.g. transferring to KMC).

Trial locations and contacts

1 site in 1 country.

Rebecca Massey, MPH, BSN, RN contact

7133482923

rebecca.elias@rice.edu

Sonia Sosa Saenz, BME contact

soniasosa@rice.edu

Nigeria1 site, 1 recruiting

  • University of Lagos, Lagos, Nigeria

    Lagos

    Chinyere Ezeaka, MBBS

    Recruiting

Other trials in Nigeria

About this study

Official title: Efficacy of Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria

The prevalence of hypothermia across low-resource settings is high, especially in countries with high neonatal mortality rates. If left untreated, hypothermia can additionally result in a significant comorbidity, and has been linked to a reduction in the effectiveness of treatment for other newborn conditions. Effective thermal care for hypothermic newborns is not widely available in low-resource settings due to cost of consumables and spare parts. In this study, the research team wish to evaluate the efficacy of a novel neonatal warming mattress in treating hypothermic newborns. Warming mattress, 'Celsi Warmer', has been developed by Rice 360 Institute for Global Health Technologies, in conjunction with African clinicians, to be a robust, low-cost, and easy-to-use warming mattress which can address the challenges of hypothermia. This is a single-arm, non-randomized, prospective intervention study. Up to 90 eligible infants at the neonatal wards of the Lagos University Teaching Hospital will be recruited to evaluate the efficacy of Celsi Warmer in rewarming hypothermic newborns. Infants temperature will be monitored during thermal intervention and the performance of the device will be evaluated. The temperatures of each infant will be compared before, during, and after the intervention.

Being tested
Celsi Warmer

What participants receive

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

  • Celsi WarmerDevice

    A trained study clinician will attach the Celsi Warmer temperature sensor to the abdomen and secure it with the abdominal belt according to the device's instruction manual (such that the temperature sensor is positioned using a vertical line from the mid-clavicular line and just below the ribs). The time of sensor placement will be recorded.

Study groups in NCT06003140
Study groupRoleWhat they receive
Hypothermic Neonates (90)ExperimentalA trained study clinician will attach the Celsi Warmer temperature sensor to the abdomen and secure it with the abdominal belt according to the device's instruction manual (such that the temperature sensor is positioned using a vertical line from the mid-clavicular line and just below the ribs). The time of sensor placement will be recorded.
Receives: Device: Celsi Warmer

What is being measured

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

  1. Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns

    To evaluate the clinical efficacy and safety of the Celsi Warmer in rewarming hypothermic newborns by comparing the Celsi Warmer's accuracy in measuring neonatal temperature compared to the gold standard, axillary temperature readings.

    Measured: 1 year

Secondary outcomes (5)

  1. Efficacy of the Device

    To assess the performance of the Celsi Warmer in rewarming hypothermic newborns by measuring the incidence of attainment of normothermia (36.5-37.5°C)

    Measured: 1 year

  2. Safety of the Device - Rate of Temperature Increase

    To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.

    Measured: 1 year

  3. Safety of the Device - Local effect of the Abdominal Belt

    To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation

    Measured: 1 year

  4. Safety of the Device - Incidence of Hyperthermia

    To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention.

    Measured: 1 year

  5. Safety of the Device - Incidence of Rebound Hypothermia

    To report any incidence of rebound hypothermia ( < 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter

    Measured: 1 year

Timeline

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

  1. First posted21 Aug 2023
  2. Study start15 Aug 2023
  3. Primary completion21 Oct 2024 (estimated)
  4. Study completion21 Oct 2024 (estimated)

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06003140
Sponsor's protocol ID
FY2023-69
Status last verified
Jun 2024
First submitted
31 May 2023
Last updated
7 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Carns J, Kawaza K, Quinn MK, Miao Y, Guerra R, Molyneux E, Oden M, Richards-Kortum R. Impact of hypothermia on implementation of CPAP for neonatal respiratory distress syndrome in a low-resource setting. PLoS One. 2018 Mar 15;13(3):e0194144. doi: 10.1371/journal.pone.0194144. eCollection 2018.

    PubMed 29543861

  • Mullany LC. Neonatal hypothermia in low-resource settings. Semin Perinatol. 2010 Dec;34(6):426-33. doi: 10.1053/j.semperi.2010.09.007.

    PubMed 21094417

  • 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

  • Cavallin F, Calgaro S, Brugnolaro V, Seni AHA, Muhelo AR, Da Dalt L, Putoto G, Trevisanuto D. Impact of temperature change from admission to day one on neonatal mortality in a low-resource setting. BMC Pregnancy Childbirth. 2020 Oct 23;20(1):646. doi: 10.1186/s12884-020-03343-7.

    PubMed 33097025

  • Ogunlesi TA, Ogunfowora OB, Ogundeyi MM. Prevalence and risk factors for hypothermia on admission in Nigerian babies <72 h of age. J Perinat Med. 2009;37(2):180-4. doi: 10.1515/JPM.2009.014.

    PubMed 18684103

Questions about this trial

What is this clinical trial studying?

A study testing Celsi Warmer in people with Neonatal Hypothermia, run by William Marsh Rice University at 1 site in Nigeria.

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 9 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: status not confirmed, as of the sponsor's last update on 7 Jun 2024. 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 Nigeria. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rebecca Massey, MPH, BSN, RN (7133482923, rebecca.elias@rice.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns (time frame: 1 year). 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 NCT06003140, which also lists 6 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 7 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in