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

Preterm Newborn Clinical Trial

— CALIPREM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757012
• Other study ID #: En cours
• Secondary ID: 2020-A01369-30
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: April 2023

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Juliana PATKAI, MD
• Phone: 033 1 58413645
• Email: juliana.patkai[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. We hypothesize an improvement of the well being of the newborn under Calinange exposition.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Newborn

Intervention

Device:
• calinange
calinange

Locations

Country	Name	City	State
France	NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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))
Secondary	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))
Secondary	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))
Secondary	Evaluate the benefits for the nurses	Evaluation questionnaire	To be completed after each use of calinange ether on day 2, 4 and 6
Secondary	Evaluate the benefits for the mother	Satisfaction questionnaire	At day 7, after the end of intervention