HeartLight: Heart Rate Monitoring for Newborn Resuscitation

NCT02701920 | Completed

• 1 other identifier: 15099
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare a newborn heart rate sensor (HeartLight) that is integrated into a hat with other common forms of heart rate monitoring such as electrocardiography (ECG), stethoscope and pulse oximetry (PO) in newborn babies. This will help to evaluate the new heart rate sensor's reliability and accuracy.

Conditions

Infant, Newborn, Diseases; Fetus or Neonate Affected by Cesarean Section; Infant, Premature, Diseases

Keywords

Premature Birth; Infant; Heart rate

Outcome Measures

Primary Outcomes (1)

• Heart Rate acquisition time in the first minute of life

  Time to acquire heart rate from new optical hat sensor from birth should be within 1 minute of birth.

  1 hour

Secondary Outcomes (5)

• Reliability of heart rate generated by HeartLight device

  1 hour

• Accuracy of heart rate generated by HeartLight device

  1 hour

• Feedback on acceptability of hat and device

  1 hour

• Thermal imaging to determine heat loss whilst wearing hat

  1 hour

• Thermal imaging to determine heat loss during stabilisation and/or resuscitation

  1 hour

Study Arms (6)

NICU infants and hat

Newborn infants of any gestation on the neonatal intensive care unit (NICU).

Device: HeartLight hat; Device: The HeartLight hat with in-built sensor

NICU infants and sensor

Newborn infants of any gestation requiring heart rate monitoring on the neonatal intensive care unit.

Device: The HeartLight hat with in-built sensor; Device: HeartLight; Device: HeartLight device

Newborns and surgical delivery

Well term newborn infants following birth by cesarean section.

Device: The HeartLight hat with in-built sensor; Device: HeartLight; Device: HeartLight device

Newborns needing stabilisation

Newborn infants requiring resuscitation or stabilisation following birth.

Device: HeartLight; Device: HeartLight device

Parental feedback

Parental feedback of babies recruited into HeartLight will be sought.

Other: parental feedback

Healthcare provider feedback

Healthcare professionals caring for babies recruited into HeartLight will have their feedback on the device sought.

Other: healthcare provider feedback

Interventions

HeartLight hat DEVICE

HeartLight hat will be worn for up to 1 hour.

NICU infants and hat

The HeartLight hat with in-built sensor DEVICE

The HeartLight hat with in-built sensor will be worn.

NICU infants and hat; NICU infants and sensor; Newborns and surgical delivery

HeartLight DEVICE

Electronic stethoscope will be used to estimate heart rate with HeartLight sensor/hat

NICU infants and sensor; Newborns and surgical delivery; Newborns needing stabilisation

HeartLight device DEVICE

HeartLight sensor/hat will be used with ECG/Pulse oximetry/electronic stethoscope

NICU infants and sensor; Newborns and surgical delivery; Newborns needing stabilisation

parental feedback OTHER

Questionnaire

Parental feedback

healthcare provider feedback OTHER

Questionnaire

Healthcare provider feedback

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants

You may qualify if:

• Written consent from the mother
• Realistic prospect of survival as determined by the attending clinical team
• Phase 1:
• \- Infants on NICU
• Phase 2:
• \- Infants on NICU requiring heart rate monitoring
• Phase 3:
• \- Newborn infants following non-emergency elective cesarean section
• Phase 4:
• \- Newborn infants who attending clinical team anticipate will require assessment of heart rate at time of birth
• Feedback:
• Mothers of babies recruited into HeartLight study
• Healthcare professionals exposed to the new device

You may not qualify if:

• Phase 1+2:
• Infants undergoing palliative care
• Infants too sick to tolerate additional procedures
• Phase 3:
• Abnormal antenatal scans suggesting significant fetal abnormality (by definition these are not routine pregnancies).
• Any infant in whom resuscitation is likely to be required.
• If multiple births then only the first baby born shall be recruited (due to resource limitations with researchers attending the birth)
• Phase 4:
• Infants \<23 weeks
• Infants that are not for active resuscitation as decided by the clinical team
• If multiple births then only the first baby born shall be recruited (due to resource limitations with researchers attending the birth)
• Feedback:
• Unable to obtain written informed consent

Sponsors & Collaborators

• University of Nottingham: lead
• Heartlight Systems Limited: collaborator

Study Sites (1)

University of Nottingham NHS Trust

Nottingham, NG72UH, United Kingdom

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases; Infant, Premature, Diseases; Premature Birth

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Don Sharkey, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 8, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: May 11, 2018
• Last Updated: May 17, 2018

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)