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

NCT04757012 | Unknown

• 2 other identifiers: En cours2020-A01369-30
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Newborn

Keywords

Preterm newborn; Maternal voice reccording; NIPE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of desaturation events

  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 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 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

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

• Evaluate the benefits for the mother

  At day 7, after the end of intervention

Study Arms (2)

Calinage exposition

EXPERIMENTAL

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

Device: calinange

no exposition

NO INTERVENTION

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

Interventions

calinange DEVICE

calinange

Calinage exposition

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, 75014, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 23890732 BACKGROUND

• 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.

  PMID: 23848529 BACKGROUND

• 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.

  PMID: 31335378 BACKGROUND

• 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.

  PMID: 29535067 BACKGROUND

Study Officials

• Juliana PATKAI, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana PATKAI, MD

CONTACT

033 1 58413645; juliana.patkai@aphp.fr

Charly LARRIEU

CONTACT

01 58 41 28 99; charly.larrieu@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 16, 2021
• Study Start: April 19, 2022
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)