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

NCT06003140 | Recruiting

• 1 other identifier: FY2023-69
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neonatal Hypothermia

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (5)

• Efficacy of the Device

  1 year

• Safety of the Device - Rate of Temperature Increase

  1 year

• Safety of the Device - Local effect of the Abdominal Belt

  1 year

• Safety of the Device - Incidence of Hyperthermia

  1 year

• Safety of the Device - Incidence of Rebound Hypothermia

  1 year

Study Arms (1)

Hypothermic Neonates (90)

EXPERIMENTAL

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.

Device: Celsi Warmer

Interventions

Celsi Warmer DEVICE

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.

Hypothermic Neonates (90)

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• William Marsh Rice University: lead
• University of Lagos, Nigeria: collaborator

Study Sites (1)

University of Lagos, Lagos, Nigeria

Lagos, Nigeria

RECRUITING

Related Publications (6)

• 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.

  PMID: 19158799 BACKGROUND

• 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.

  PMID: 29543861 BACKGROUND

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

  PMID: 21094417 BACKGROUND

• 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.

  PMID: 23369256 BACKGROUND

• 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.

  PMID: 33097025 BACKGROUND

• 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.

  PMID: 18684103 BACKGROUND

Study Officials

• Chinyere Ezeaka, MBBS, MPH

  College of Medicine, University of Lagos, Lagos, Nigeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Massey, MPH, BSN, RN

CONTACT

7133482923; rebecca.elias@rice.edu

Sonia Sosa Saenz, BME

CONTACT

soniasosa@rice.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: August 21, 2023
• Study Start: August 15, 2023
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)