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Completed

NCT Number: NCT04757012

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

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.

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Key information

Conditions

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

calinange

Device

calinange

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: CALIPREM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2021
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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