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Pain of Premature Babies and RetCam (DOLICAM)

NCT04092127 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2022-06-14

No results posted yet for this study

Summary

It is a single-center prospective observational descriptive study.

studied population is premature infants, hospitalized in the neonatology department of the University Hospital of Grenoble and for whom the RetCam examination is planned for screening for retinopathy of prematurity if they are at risk (prematurity \<32 weeks).

To measure their pain during the examination, it will be a matter of filming the face of the child for 15 seconds before the examination, then 2 times 30 seconds at two distinct times. The PIPP (Premature Infant Pain Profile) score includes a percentage of time on these 30 seconds where 3 items are found modified and a monitoring of heart rate and oxygen saturation.This time calculation can not be done live and requires video recording of the child's face during the exam.

The statistical analyzes will be adjusted for sex, gestational age at birth, weight, and pain from birth (determined by the number of doses of level 1 analgesics received by the baby and the number of days (from birth to to the RetCam examination) when the baby received \> level 1 analgesics).

Conditions

  • Premature Infant Disease
  • Retinopathy of Prematurity

Interventions

OTHER

Video Record

Video Record of the premature infant face before and during the RetCam screening of retinopathy of prematurity

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Thierry Debillon, MD PhD · University Hospital, Grenoble

Eligibility

Max Age
4 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2020-06-15
Completion
2020-06-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04092127 on ClinicalTrials.gov