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Benefit of Singing in the Care of Premature Children Undergoing Screening for Retinopathy of Prematurity in the Neonatology and Neonatal Resuscitation Unit of the Dijon University Hospital (Voix Chantée)

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ClinicalTrials.gov Identifier: NCT03830580
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

As part of the regular procedure for premature births, premature infants undergo several screening examinations, including an examination of the fundus. This examination seeks to establish whether the infant has retinopathy of prematurity. This disease affects the vessels of the retina of the eye, especially in prematurely born children, and can lead to serious complications such as blindness if it is not treated in time.

The purpose of this study is to assess the discomfort caused by the screening in order to improve practices. To do this, the investigators would like to evaluate whether soft auditory stimulation, more precisely a person singing, would improve the children's level of comfort during the examination.

To do this, the participating children will be divided into 2 groups:

  • The "Singing" group will receive the usual comfort treatments (placed in a 'nest', pacifier and sugar water) and a trained professional will sing a lullaby or nursery rhyme at the same time
  • control group will receive the usual comfort care (placed in a 'nest', pacifier and sugar water) The child's head and entire body will be filmed, which will allow an evaluator to assess the child's comfort.

Condition or disease Intervention/treatment Phase
Prematurity Eye Fundus Other: Positive stimulation (singing) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Benefit of Singing in the Care of Premature Children Undergoing Screening for Retinopathy of Prematurity in the Neonatology and Neonatal Resuscitation Unit of the Dijon University Hospital
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sung voice Other: Positive stimulation (singing)
A nurse or assistant trained in singing with an operal singer sings a lullaby She sits next to the incubator and sings from the time the sucrose is administered (2 minutes before the fundus exams is performed) until the end of the examination - taking into account the child's reaction

No Intervention: Control



Primary Outcome Measures :
  1. Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale [ Time Frame: During the examination ]
    The children's faces and bodies will be filmed - without sound - during the examination. The nurse who examines the fundus will start and finish the video recording.



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Ages Eligible for Study:   1 Month to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infant born prematurely before the end of 31 weeks of amenorrhoea and/or with a birth weight of less than 1250g
  • Infant in whom a first screening examination (fundus) for retinopathy of prematurity (i.e. around 32 WA) must be carried out according to term by hospital protocol
  • Infant hospitalized in the neonatal paediatrics and intensive care unit of the Dijon University Hospital
  • Infant affiliated to the national medical insurance system
  • Oral agreement of one of the two parents

Exclusion Criteria:

  • Infants with contraindications to the use of Algopedol® 24% sugar solution, NEOSYNEPHRINE 2.5% mydriatic eye drops for pupillary dilatation, MYDRIATICUM 0.5% mydriatic eye drops for pupillary dilatation and OXYBUPROCAINE analgesic eye drops
  • Infant with known deafness and no hearing aid
  • Premature infant in critical condition
  • Infant with hemodynamic and clinical instability making it impossible to perform the fundus examination because of the risk of decompensation
  • Parent refuses the videotaping

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830580


Contacts
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Contact: Anne-Cécile CHARY-TARDY 03.80.29.33.62 annececile.charytardy@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne Not yet recruiting
Dijon, France, 21000
Contact: Anne-Cécile CHARY-TARDY    03.80.29.33.62    annececile.charytardy@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03830580     History of Changes
Other Study ID Numbers: CHARY-TARDY 2018
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Premature Birth
Retinopathy of Prematurity
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Retinal Diseases
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases