Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Study of a Device Allowing Broadcasting Maternal Voice and Heartbeat in Preterm Newborn (CALIPREM) (CALIPREM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04757012
Recruitment Status : Not yet recruiting
First Posted : February 16, 2021
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the benefits of an exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns. For that, we use of a specific neonatal device "Calinange" able to record maternal voice and heartbeats and to restore it with a sound level control. We hypothesize an improvement of the well being of the newborn under Calinange exposition.

Condition or disease Intervention/treatment Phase
Preterm Newborn Device: calinange Not Applicable

Detailed Description:
Immediately after birth, preterm newborns are immersed in a hostile environment of intensive care unit with light, sound and painful stimulations. Previously, exposure to maternal voice has demonstrated improvement on infants' statements: reduction of bradycardia, desaturation events, improvement of tolerance feeding and sleep. Unfortunatly in most of the N ICU in France, the mothers' presence attendance time is reduced because of the absence of accommodation structure. The use of a specific neonatal device able to daily record maternal voice and hearbeats and to restore it when mother is gone could improve the environment and promote the well-being of the newborn.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pilot Study to Evaluate the Benefits of Preterm Newborn Exposition to a Maternal Voice and Heardbeat Recording During Hospital Stay
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : February 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: calinange
    calinange

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Heart rate variability / NIPE Index [ Time Frame: Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5)) ]
    Recorded heart rate


Secondary Outcome Measures :
  1. Number of desaturation events [ Time Frame: Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5)) ]
    Change in desaturation events before and after intervention

  2. Number of apnoeic events [ Time Frame: Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5)) ]
    Change in apneic events before and after intervention

  3. Number of bradycardia events [ Time Frame: Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5)) ]
    Change in bradycardia events before and after intervention

  4. Evaluate the benefits for the nurses [ Time Frame: To be completed after each use of calinange ether on day 2, 4 and 6 ]
    Evaluation questionnaire

  5. Evaluate the benefits for the mother [ Time Frame: At day 7, after the end of intervention ]
    Satisfaction questionnaire


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hospitalised premature newborn in Port-Royal NICU
  • age between 3 and 6 daysof life
  • gestational age between 27+0 and 31+6 weeks
  • hospitalisation in one bed room
  • parental consents
  • beneficiaries social security scheme

Exclusion Criteria

  • occurrence of one or more non-inclusion criteria
  • Non-inclusion Criteria:
  • Chromosomal abnormality, severe congenital malformation
  • Toxic substance consumption during pregnancy
  • Sedative medication in progress, High frequencies ventilation in progress
  • Neurological damage: intraventricular haemorrhage stage 3 and 4, bilateral and expanse periventricular leukomalacia lesions
  • Severe infectious state requiring haemodynamic support (inotropic drugs or hemissucinate)
  • Participation to a other intervention research
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04757012


Contacts
Layout table for location contacts
Contact: Juliana PATKAI, MD 033 1 58413645 juliana.patkai@aphp.fr

Locations
Layout table for location information
France
NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital
Paris, France, 75014
Contact: Juliana PATKAI, MD    0033 1 58413645    juliana.patkai@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Juliana PATKAI, MD Service de Médecine et Réanimation néonatales de Port-Royal APHP.Centre - Université de Paris. Site Cochin.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04757012    
Other Study ID Numbers: En cours
2020-A01369-30 ( Other Identifier: ID-RCB Number )
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Preterm newborn
Maternal voice reccording
NIPE
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications