Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04292015
Other study ID # DHRD/2017/043
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 14, 2017
Est. completion date January 22, 2018

Study information

Verified date February 2020
Source University Hospitals of Derby and Burton NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ROP is a preventable cause of blindness in premature infants. It is routinely screened for by using an indirect ophthalmoscope, a scleral depressor, and a condensing lens. This method of screening can cause significant cardiorespiratory distress to infants. A new camera (Optos California) has recently been used to image infants with different severities of ROP. The Optos California is capable of capturing up to 200 degrees of retina in a single image without contact with the eye. The non eye contact nature of the Optos California may cause less distress to infants who are due a ROP screening examination. The present study is to compare the impact of ROP screening examination between the Optos retinal camera and conventional binocular indirect ophthalmoscopy using cardiorespiratory indices (such as heart rate, oxygen saturations, blood pressure, and respiratory rate) as a measure of distress.


Description:

This is a pilot prospective randomised study. As part of the routine clinical care at RDH, all premature infants eligible for ROP screening as stated by the UK ROP screening guidelines will undergo the gold standard screening examination by a Consultant Ophthalmologist.

Each infant eligible for ROP screening will be routinely scheduled for several ROP screening examinations prior to discharge from the neonatal unit. For each infant who is eligible and whose parent(s) or legal guardian have agreed for them to be enrolled in the study, two additional procedures to the gold standard examination with the binocular indirect ophthalmoscope (as stated above) will be carried out at each of its routinely scheduled ROP screening examination.

The first additional procedure will be the acquisition of images of both fundi by Ophthalmology Specialty Registrar with the Optos ultra-widefield retinal-imaging device. Cardiorespiratory indices will be collected at different time points of the Optos retinal imaging procedure.

The second additional procedure will be the collection of cardiorespiratory indices (including the heart rate,respiratory rate, oxygen saturations, and blood pressure) by the paediatric research nurse at the time of the gold standard examination with the binocular indirect ophthalmoscope. The equipment used will be the same as those used to measure the cardiorespiratory indices during different time points of the Optos ultra-widefield retinal imaging procedure (see above).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 22, 2018
Est. primary completion date January 22, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Infants eligible for routine ROP screening using UK ROP screening guidelines (Any infant born at or before 32 weeks gestation and/or weigh 1500 grams or less).

- Infants with parents who have conversational English and who can give written informed consent.

Exclusion Criteria:

- Infants not eligible for routine ROP screening under UK ROP screening guidelines.

- Infants who are deemed not well enough by a consultant neonatologist (SO) for retinal examination or retinal imaging.

- Any premature infant with media opacities that prevents adequate visualisation of the retina.

- Inability of the parents to understand verbal and written English.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Optos ultra-widefield retinal imaging (Optos California)
retinal imaging device

Locations

Country Name City State
United Kingdom University Hospitals of Derby & Burton NHS Foundation Trust Derby Derbyshire

Sponsors (1)

Lead Sponsor Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure (BP) Blood pressure (BP) Baseline to 10 minutes following completion of both interventions
Primary Number of infants that develop bradycardia Defined as less than 100 beats per minute Baseline to 10 minutes following completion of both interventions
Primary Oxygen saturation Number of infants who develop oxygen saturations below 85% Baseline to 10 minutes following completion of both interventions
Primary Development of respiratory distress Number of infacnts who develop respiratory distress, defined as respiratory rate less than 30 breaths per minute Baseline to 10 minutes following completion of both interventions
Secondary Determine and compare time taken to perform interventions Time of each intervention recorded During intervention
See also
  Status Clinical Trial Phase
Completed NCT04200807 - Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics
Active, not recruiting NCT05282628 - I-InTERACT Preterm N/A
Recruiting NCT04717037 - Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS) Phase 2/Phase 3
Completed NCT05017727 - Closed-loop Oxygen Control in Ventilated Infants Born at or Near Term
Completed NCT04633551 - Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes N/A
Completed NCT04295395 - Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants
Recruiting NCT05383586 - MusicHyperBrain Study With Preterm Infants and Their Parents N/A
Not yet recruiting NCT04812249 - Effect of Co-morbidities on the Development of Oral Feeding Ability in Pre-term Infants
Recruiting NCT03966170 - Citicoline as Neuroprotector in Preterm Phase 3
Completed NCT05863481 - Obstetric Outcome in Pregnancies Treated With Laparoscopic Cerclage
Recruiting NCT06414655 - Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China
Completed NCT04002908 - Low-birthweight Infant Feeding Exploration
Recruiting NCT05404594 - Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants N/A
Not yet recruiting NCT05188066 - Study of Pregnancy Pathologies Associated With Placental Abnormalities
Not yet recruiting NCT05629910 - NeO2Matic-Pilot Trial N/A
Completed NCT04811872 - Placental Transfusion Effect on Hemodynamics of Premature Newborns Phase 2/Phase 3
Completed NCT04785183 - Antioxidant Effects of Melatonin in Preterm N/A
Not yet recruiting NCT05243901 - EPIPAGE 2 - 10-year Follow-up (RECONAI PROJECT)
Not yet recruiting NCT04333121 - Modelling Weight Reference Centiles for Preterm Infants
Not yet recruiting NCT04351425 - Early Weaning of Preterm Newborn From Incubator to Cot at 1400 Grams N/A