Response of Preterm Infants to Multisensory Stimuli

NCT04665440 | Terminated

• 1 other identifier: 2020-00101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to measure the variation of oxytocin and cortisol levels in the saliva of premature neonates and their mother after sensorial stimuli.

Conditions

Mother-Infant Interaction

Keywords

neonates; oxytocin; late preterm; stress; family-centered intervention

Outcome Measures

Primary Outcomes (1)

• Oxytocin/cortisol ratio

  Change in salivary oxytocin/cortisol ratio in response to the intervention

  at baseline and 10 minutes after intervention

Secondary Outcomes (3)

• Vital signs

  at baseline, during and 10 minutes after intervention

• Facial expression analysis

  at baseline, during and 10 minutes after intervention

• mother anxiety and mother infant bond

  at baseline and 10 minutes after intervention

Study Arms (2)

Voice only then distraction

OTHER

First intervention: mother's voice without tactile stimuli Second intervention: mother's voice with tactile stimuli

Other: Voice alone; Other: Voice + tactile stimuli

Distraction then voice only

OTHER

First intervention: mother's voice with tactile stimuli Second intervention: mother's voice without tactile stimuli

Other: Voice alone; Other: Voice + tactile stimuli

Interventions

Voice alone OTHER

mother's voice without tactile stimuli

Distraction then voice only; Voice only then distraction

Voice + tactile stimuli OTHER

mother's voice with tactile stimuli

Distraction then voice only; Voice only then distraction

Eligibility Criteria

• Age: 32 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn gestational age 32 0/7 weeks to 34 6/7 weeks
• Born at university hospital Geneva
• French speaking parents
• Out of incubator
• Signed consent

You may not qualify if:

• Newborn with one of the above conditions:
• Congenital malformation
• intraventricular hemorrhage grade III or IV
• white matter abnormality
• anti-epileptic or sedative drugs
• altered consciousness level
• Infant requiring respiratory support
• psychiatric disorders in the mother or antenatal use of psychoactive drugs
• Bilateral absent otoacoustic emissions and/or auditory evoked potential
• Parents refusal to participate

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Hôpitaux Universitaires Genève

Geneva, Switzerland

Location

Related Publications (6)

• Filippa M, Panza C, Ferrari F, Frassoldati R, Kuhn P, Balduzzi S, D'Amico R. Systematic review of maternal voice interventions demonstrates increased stability in preterm infants. Acta Paediatr. 2017 Aug;106(8):1220-1229. doi: 10.1111/apa.13832. Epub 2017 Apr 19.

  PMID: 28378337 BACKGROUND

• Weber A, Harrison TM, Sinnott L, Shoben A, Steward D. Plasma and Urinary Oxytocin Trajectories in Extremely Premature Infants During NICU Hospitalization. Biol Res Nurs. 2017 Oct;19(5):549-558. doi: 10.1177/1099800417718266. Epub 2017 Jul 12.

  PMID: 28699358 BACKGROUND

• Vittner D, McGrath J, Robinson J, Lawhon G, Cusson R, Eisenfeld L, Walsh S, Young E, Cong X. Increase in Oxytocin From Skin-to-Skin Contact Enhances Development of Parent-Infant Relationship. Biol Res Nurs. 2018 Jan;20(1):54-62. doi: 10.1177/1099800417735633. Epub 2017 Oct 11.

  PMID: 29017336 BACKGROUND

• Zinni M, Colella M, Batista Novais AR, Baud O, Mairesse J. Modulating the Oxytocin System During the Perinatal Period: A New Strategy for Neuroprotection of the Immature Brain? Front Neurol. 2018 Apr 13;9:229. doi: 10.3389/fneur.2018.00229. eCollection 2018.

  PMID: 29706926 BACKGROUND

• Lejeune F, Brand LA, Palama A, Parra J, Marcus L, Barisnikov K, Debillon T, Gentaz E, Berne-Audeoud F. Preterm infant showed better object handling skills in a neonatal intensive care unit during silence than with a recorded female voice. Acta Paediatr. 2019 Mar;108(3):460-467. doi: 10.1111/apa.14552. Epub 2018 Sep 21.

  PMID: 30144160 BACKGROUND

• Kuhn P, Sizun J, Casper C; GREEN study group from the French Neonatal Society. Recommendations on the environment for hospitalised newborn infants from the French neonatal society: rationale, methods and first recommendation on neonatal intensive care unit design. Acta Paediatr. 2018 Nov;107(11):1860-1866. doi: 10.1111/apa.14501. Epub 2018 Aug 13.

  PMID: 30025190 BACKGROUND

MeSH Terms

Interventions

Voice

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: prospective randomised crossover study

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 11, 2020
• Study Start: September 1, 2020
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

CH (1)