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Preterm NewbornCALIPREMNCT04757012

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

A study testing calinange in people with Preterm Newborn, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 7 days
Conditions the study is for
Preterm Newborn
What is being tested?
calinange
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
19 Apr 2022to 18 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 7 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Paris, 75014

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Preterm Newborn
Being tested
calinange
Keywords
Preterm newborn, Maternal voice reccording, NIPE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • calinangeDevice

    calinange

Study groups in NCT04757012
Study groupRoleWhat they receive
Calinage expositionExperimentalexposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D2, D4 and D6
Receives: Device: calinange
no expositionNo interventionNo exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D1, D3 and D5

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart rate variability / NIPE Index

    Recorded heart rate

    Measured: 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 outcomes (5)

  1. Number of desaturation events

    Change in desaturation events before and after intervention

    Measured: 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))

  2. Number of apnoeic events

    Change in apneic events before and after intervention

    Measured: 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))

  3. Number of bradycardia events

    Change in bradycardia events before and after intervention

    Measured: 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))

  4. Evaluate the benefits for the nurses

    Evaluation questionnaire

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

  5. Evaluate the benefits for the mother

    Satisfaction questionnaire

    Measured: At day 7, after the end of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2021
  2. Study start19 Apr 2022
  3. Primary completion18 Jun 2023
  4. Study completion18 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04757012
Sponsor's protocol ID
APHP200731
Other IDs
2020-A01369-30
Acronym
CALIPREM
Status last verified
Jun 2026
First submitted
24 Jan 2021
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23890732

  • 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.

    PubMed 23848529

  • 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.

    PubMed 31335378

  • 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.

    PubMed 29535067

Questions about this trial

What is this clinical trial studying?

A study testing calinange in people with Preterm Newborn, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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))). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04757012, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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