Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy

NCT03230032 | Completed DMC FDA Device

• 1 other identifier: IRB16-00862
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The study seeks to determine the efficacy of non-nutritive suck (NNS) training using a pacifier-activated device (PAM) with mothers' voice to condition suck-strength and rhythmicity, in improving the feeding and developmental outcomes of infants at high-risk for CP.

Conditions

Infant Development; Infant,Premature; Hydrocephalus; Neonatal Encephalopathy; Infarction; PVL; Thrombosis; Intraventricular Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Oral Feeding Efficiency

  Continuous measure of suck strength and suck rate during non-nutritive suck via PAM sensor, as well as suck burst pattern and average oral feeding volumes.

  Twelve months

Secondary Outcomes (4)

• HINE

  3-4 month and 12 month assessments

• Bayley-III

  3-4 months and 12 month assessments

• Oral feeding development questionnaire

  3-4 months and 12 month assessments

• NOMAS

  33-41 weeks PMA and 35-43 weeks PMA

Study Arms (2)

Intervention Group

EXPERIMENTAL

Sessions will use a pacifier-activated device (PAL) system. The device sensor attaches to a routinely-used pacifier and measures timing and pressure of the sucks. If the infant reaches the preset suck pressure, he receives 10 seconds of mother's voice. The receiver/speaker box controls the volume to \< 65dB on scale C. PAM will be set to the lowest settings for the first session. Using sensor measurements, the therapist will increase the threshold for number of sucks and strength once the infant produces three consecutive sucks above current level and continue per protocol.

Device: pacifier-activated device

Control Group

NO INTERVENTION

Infants will receive 2 daily 15-min listening sessions of mother's voice recording, contiguous but not simultaneous with PAM NNS sessions without suck-contingent reinforcement (no voice).

Interventions

pacifier-activated device DEVICE

The utilization of the pacifier-activated-music player combines the sound of the mother's voice with a pacifier routinely used with each patient during their inpatient NICU stay

Also known as: PAL

Intervention Group

Eligibility Criteria

• Age: 32 Weeks - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• PMA at enrollment \>32 6/7 and \<42 AND
• Diagnoses of Grade III/IV IVH, hydrocephalus or PVL, neonatal encephalopathy or thrombosis/infarct with involvement of the posterior limb of the internal capsule OR
• Abnormal GMA by certified study staff and masked gold-standard reading

You may not qualify if:

• on assisted ventilation
• receiving more than 50% of their feeds orally averaged over the 72 hours prior to study start
• receiving less than 50% of their feeds enterally
• receiving enteral feed for greater than 60 min.
• considered medically unsafe to feed orally by the medical or feeding team as defined by unit/clinical protocol

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Cerebral Palsy Alliance: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• Kjeldsen CP, Neel ML, Stark AR, He Z, Chorna O, Benninger K, Maitre NL. Contingent mother's voice intervention facilitates attention in hospitalized preterm infants with neural insults. Mind Brain Educ. 2025 Feb;10(1):37-46. doi: 10.1111/mbe.70000. Epub 2025 Feb 22.

  PMID: 40486963 DERIVED

MeSH Terms

Conditions

Premature Birth; Hydrocephalus; Infarction; Thrombosis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nathalie L Maitre, MD, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: There participants will be randomized to two groups: PAL (pacifier and mother's voice provided contingently on sucking behavior) or Sounds of Love (listening to mother's voice not contingent upon sucking behavior on the pacifier, but pacifier available, per standard of care). To allow for high repetitiveness of the treatment, participants in both groups will receive 2 daily 15-min sessions of the intervention or control treatments for a total of 20 sessions. Sessions occur 15-30 min prior to feeding.

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 26, 2017
• Study Start: June 9, 2017
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

US (1)