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

Primary Purpose

Preterm Newborn

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

calinange

About this trial

This is an interventional supportive care trial for Preterm Newborn focused on measuring Preterm newborn, Maternal voice reccording, NIPE

Eligibility Criteria

undefined - 7 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NICU of Port-Royal, Maternity of Port-Royal, Cochin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Calinage exposition

no exposition

Arm Description

exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D2, D4 and D6

No exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D1, D3 and D5

Outcomes

Primary Outcome Measures

Heart rate variability / NIPE Index

Recorded heart rate

Secondary Outcome Measures

Number of desaturation events

Change in desaturation events before and after intervention

Number of apnoeic events

Change in apneic events before and after intervention

Number of bradycardia events

Change in bradycardia events before and after intervention

Evaluate the benefits for the nurses

Evaluation questionnaire

Evaluate the benefits for the mother

Satisfaction questionnaire

Full Information

NCT ID

NCT04757012

First Posted

January 24, 2021

Last Updated

September 26, 2022

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT04757012

Brief Title

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

Acronym

CALIPREM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 19, 2022 (Actual)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Newborn

Keywords

Preterm newborn, Maternal voice reccording, NIPE

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Calinage exposition

Arm Type

Experimental

Arm Description

exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D2, D4 and D6

Arm Title

no exposition

Arm Type

No Intervention

Arm Description

No exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D1, D3 and D5

Intervention Type

Device

Intervention Name(s)

calinange

Intervention Description

calinange

Primary Outcome Measure Information:

Title

Heart rate variability / NIPE Index

Description

Recorded heart rate

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))

Secondary Outcome Measure Information:

Title

Number of desaturation events

Description

Change in desaturation events before and after intervention

Time Frame

Title

Number of apnoeic events

Description

Change in apneic events before and after intervention

Time Frame

Title

Number of bradycardia events

Description

Change in bradycardia events before and after intervention

Time Frame

Title

Evaluate the benefits for the nurses

Description

Evaluation questionnaire

Time Frame

To be completed after each use of calinange ether on day 2, 4 and 6

Title

Evaluate the benefits for the mother

Description

Satisfaction questionnaire

Time Frame

At day 7, after the end of intervention

10. Eligibility

Sex

All

Maximum Age & Unit of Time

7 Days

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Juliana PATKAI, MD

Phone

033 1 58413645

juliana.patkai@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Charly LARRIEU

Phone

01 58 41 28 99

charly.larrieu@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juliana PATKAI, MD

Organizational Affiliation

Service de Médecine et Réanimation néonatales de Port-Royal APHP.Centre - Université de Paris. Site Cochin.

Official's Role

Principal Investigator

Facility Information:

Facility Name

NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital

City

Paris

ZIP/Postal Code

75014

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juliana PATKAI, MD

Phone

0033 1 58413645

juliana.patkai@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23890732

Citation

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.

Results Reference

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PubMed Identifier

23848529

Citation

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.

Results Reference

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PubMed Identifier

31335378

Citation

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.

Results Reference

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PubMed Identifier

29535067

Citation

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.

Results Reference

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

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