Skip to main content
OpenTrials
Completed

NCT Number: NCT03372590

NEO Rehab for Infants at Risk of Cerebral Palsy

Premature infants are at increased risk of developing cerebral palsy (CP). Early interventions for at risk infants have the potential to decrease disease severity and improve quality of life. All infants demonstrate general movements (GMs), which are reliable indicators of brain function and can be reproducibly evaluated using the General Movement Assessment (GMA) tool.

Prior studies have demonstrated the impact of early maternal-driven intervention strategies on neurodevelopmental outcomes in preterm infants. Investigators have shown that interventions promoting the establishment of emotional connection between the infant and his or her mother, including mother/infant calming sessions with scent cloth exchange, vocal soothing, eye contact, and kangaroo care, can impact neurodevelopmental outcomes at 18 months. Investigators have also shown that 60 minutes of kangaroo care leads to decreasing levels of the stress hormone cortisol in both mothers and infants.

This pilot study aims to determine the feasibility of a maternal-driven early intervention bundle in preterm infants with abnormal GMA.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prematurity Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Female Urogenital Diseases and Pregnancy Complications Nervous System Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

The study objective are 3-fold:

  • To determine the proportion of infants (<32 weeks gestation and/or <1500g) who have abnormal GMs findings using the GMA tool.
  • To determine the feasibility of NICU based rehabilitation program in 20 infants determined to be at high risk for CP using the GMA tool. The intervention bundle will consist of a maternal-driven gestational age (GA)-appropriate intervention bundle that will include evidence-based interventions including vocal soothing, comforting touch, scent exchange, kangaroo care, and infant massage. Patients will be compared to contemporary and GA-matched controls receiving standard of care with a 1:2 assignment.
  • To evaluate the short-term impact of a maternal-driven intervention bundle on the mother-infant dyad. Maternal stress will be measured using the Parental Stress Scale for NICU patients (PSS: NICU) prior to the intervention and prior to the infant's NICU discharge. Further, stress will be assessed by measuring maternal and infant salivary cortisol pre-and post-kangaroo care on 3 separate occasions (post enrollment in the study, mid-hospital stay, and prior to discharge). Measures of maternal anxiety and depression will be evaluated prior to the intervention and prior to NICU discharge using the Patient Reported Outcomes Measurement Information System (PROMIS) instrument.

The investigators hypothesize that the intervention will lead to positive and measurable outcomes for the mother-infant dyad.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infant Gestational age <32 weeks AND/OR birth weight <1500g

Exclusion criteria

  • Any clinical condition / diagnosis that would restrict the ability of the mother to do Kangaroo Care per the current UVA Kangaroo Care guideline
  • Non-English-speaking mother
  • Mother is a prisoner
  • Confirmed inability to return for follow-up appointment

Treatment and study plan

NICU-based rehabilitation bundle

Other

Maternal-driven gestational age-appropriate intervention/activity bundle, including the evidence-based elements of vocal soothing, comforting touch, scent exchange, kangaroo care, and infant massage

Other names: scent exchange, kangaroo care, massage, vocal soothing, comforting touch

Standard of care

Other

Standard NICU care

Primary outcomes

  1. NICU-based rehabilitation program feasibility

    Time frame: 2 years

    The feasibility of a maternal driven intervention bundle will be assessed using a maternal diary and unannounced observations. The ability to perform the required intervention greater than 75% of the time will be considered successful

Secondary outcomes

  1. Evolution of GMA patterns in high risk infants

    Time frame: 2 years

    GME will be scored on enrollment and at NICU discharge

  2. Impact on maternal stress and depression

    Time frame: 2 years

    Assessed on enrollment and NICU discharge using the PSS-NICU and PROMIS instrument

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

NEO Rehabilitation Program for Premature Infants at Risk for Cerebral Palsy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2017
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.