Clinical trial NCT03230032: Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy
Official title: RCT of Feeding Intervention With Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Infant,Premature
Hydrocephalus
Neonatal Encephalopathy
Infarction
PVL
Thrombosis
Intraventricular Hemorrhage
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Cerebral Palsy Alliance
First posted: 2017-07-26
Enrollment: 130
Sex: ALL
Minimum age (years): 32
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria: Infants cannot be

* 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

Primary outcomes:
measure: Oral Feeding Efficiency
timeFrame: Twelve months
Secondary outcomes:
measure: HINE
timeFrame: 3-4 month and 12 month assessments
measure: Bayley-III
timeFrame: 3-4 months and 12 month assessments
measure: Oral feeding development questionnaire
timeFrame: 3-4 months and 12 month assessments
measure: NOMAS
timeFrame: 33-41 weeks PMA and 35-43 weeks PMA
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Nathalie L Maitre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: