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

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ClinicalTrials.gov Identifier: NCT03230032
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
Cerebral Palsy Alliance
Information provided by (Responsible Party):
Nathalie Maitre, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Infant Development Infant,Premature Hydrocephalus Neonatal Encephalopathy Infarction PVL Thrombosis Intraventricular Hemorrhage Device: pacifier-activated device Not Applicable

Detailed Description:

Poor neuromotor and sensory function of the aerodigestive system in children with CP often originates in the neonatal period, when they are still classified as "high-risk for CP". Characteristic neuroimaging abnormalities including severe intraventricular (IVH) hydrocephalus and periventricular leukomalacia (PVL), stroke or ischemia with lesions affect the posterior limb of the internal capsule are strong Indicators of high-risk for CP, especially when combined with abnormal General Movements Assessment (Guidelines for Early Detection of CP; Stockholm, 2016). Early intervention, when plasticity is greatest has the largest impact on functional recovery in CP. While intervening in infancy involves treating some infants who will not develop CP, the goal is to establish new neuronal connections and functional patterns before less efficient adaptations can occur. However, no current interventions target the oral-motor dysfunction of infants at high-risk for CP, before their discharge from the NICU.

Evidence for behavioral interventions in feeding disorders for children with CP ranges from insufficient to moderate, with a clear need for rigorous studies. In healthy preterm and late-preterm infants, oromotor practice opportunities such as non-nutritive suck (NNS) are safe and promote effective suck-swallow-breathe patterns, with decreased time to achieving oral feeds. While NNS opportunities are frequent in most NICUs, they must be adapted for effectiveness in infants at high-risk for CP. Motor learning in these infants must incorporate repetitive, self-initiated and task-directed activities. Learning is optimized when contingent on feedback, such as positive reinforcement.

NNS training (rather than simple exposure) has been implemented successfully using rhythmic sound of mother's voice singing contingent upon suck strength and pattern, as detected by a pacifier-sensor device (Pacifier-activated music; PAM) in an cohort of predominantly healthy preterm infants. An RCT demonstrated that NNS-trained infants had feeding tubes removed one week earlier than controls, with fewer aspiration events and feeding difficulties in infancy. The intervention was promising in the dozen infants with significant neural injury. Following this preliminary data, this study seeks to further determining 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: RCT of Feeding Intervention With Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy.
Actual Study Start Date : June 10, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention Group
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
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
Other Name: PAL
No Intervention: Control Group
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).



Primary Outcome Measures :
  1. Oral Feeding Skills [ Time Frame: 12 months ]
    Demonstrate that non-nutritive suck training with PAM/ mother's voice will result in improved oral feeding skills before discharge as compared to control infants receiving mother's voice separate from pacifier sucking.


Secondary Outcome Measures :
  1. Neurodevelopmental assessment scores [ Time Frame: 3-4 month and 12 month assessments ]
    Hammersmith Infant Neurologic Exam and Bayley Scales of Infant Development



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Ages Eligible for Study:   32 Weeks to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The study population will comprise infants with a (1) PMA at enrollment >32 6/7, and (2) 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 (3) abnormal GMA by certified study staff and masked gold-standard reading.

Exclusion Criteria:

  • Infants cannot be on assisted ventilation;considered medically unsafe to feed orally by the medical or feeding team; 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230032


Contacts
Contact: Nathalie Maitre, MD, PhD 614-935-6626 nathalie.maitre@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Nathalie Maitre, MD, PhD    614-935-6626    nathalie.maitre@nationwidechildrens.org   
Sponsors and Collaborators
Nationwide Children's Hospital
Cerebral Palsy Alliance
Investigators
Principal Investigator: Nathalie L Maitre, MD, PhD Nationwide Children's Hospital

Responsible Party: Nathalie Maitre, Associate Professor and Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03230032     History of Changes
Other Study ID Numbers: IRB16-00862
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hydrocephalus
Infarction
Hemorrhage
Thrombosis
Cerebral Palsy
Brain Diseases
Cerebral Hemorrhage
Ischemia
Pathologic Processes
Necrosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Brain Damage, Chronic
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders