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

Pilot Study to Evaluate the Benefits of Preterm Newborn Exposition to a Maternal Voice and Heardbeat Recording During Hospital Stay

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Newborn
• Intervention / Treatment: Device: calinange

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charly LARRIEU; Phone Number: 01 58 41 28 99; Email: charly.larrieu@aphp.fr
• Study Contact Backup: Name: Juliana PATKAI, MD; Phone Number: 033 1 58413645; Email: juliana.patkai@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital
    • Contact: Juliana PATKAI, MD; Phone Number: 0033 1 58413645; Email: juliana.patkai@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calinage exposition; exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D2, D4 and D6	Device: calinange; calinange
No Intervention: no exposition; No exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D1, D3 and D5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability / NIPE Index	Recorded heart rate	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))

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of desaturation events	Change in desaturation events before and after intervention	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))
Number of apnoeic events	Change in apneic events before and after intervention	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))
Number of bradycardia events	Change in bradycardia events before and after intervention	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))
Evaluate the benefits for the nurses	Evaluation questionnaire	To be completed after each use of calinange ether on day 2, 4 and 6
Evaluate the benefits for the mother	Satisfaction questionnaire	At day 7, after the end of intervention

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Juliana PATKAI, MD, Service de Médecine et Réanimation néonatales de Port-Royal APHP.Centre - Université de Paris. Site Cochin.

Publications and helpful links

General Publications

• Provenzi L, Broso S, Montirosso R. Do mothers sound good? A systematic review of the effects of maternal voice exposure on preterm infants' development. Neurosci Biobehav Rev. 2018 May;88:42-50. doi: 10.1016/j.neubiorev.2018.03.009. Epub 2018 Mar 10.
• Alexandre C, De Jonckheere J, Rakza T, Mur S, Carette D, Logier R, Jeanne M, Storme L. [Impact of cocooning and maternal voice on the autonomic nervous system activity in the premature newborn infant]. Arch Pediatr. 2013 Sep;20(9):963-8. doi: 10.1016/j.arcped.2013.06.006. Epub 2013 Jul 23. French.
• Filippa M, Devouche E, Arioni C, Imberty M, Gratier M. Live maternal speech and singing have beneficial effects on hospitalized preterm infants. Acta Paediatr. 2013 Oct;102(10):1017-20. doi: 10.1111/apa.12356. Epub 2013 Aug 8.
• Williamson S, McGrath JM. What Are the Effects of the Maternal Voice on Preterm Infants in the NICU? Adv Neonatal Care. 2019 Aug;19(4):294-310. doi: 10.1097/ANC.0000000000000578.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Preterm newborn; Maternal voice reccording; NIPE
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: En cours; 2020-A01369-30 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No