Supporting and Enhancing NICU Sensory Experiences to Optimize Developmental Outcomes in Preterm Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age
Study Overview
Brief Summary
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St. Louis Children's Hospital (SLCH) who were hospitalized in a private NICU room were recruited. The parents of infants in the sensory-based intervention group were educated and supported by trained therapists to give different positive sensory experiences to their infants while hospitalized. The traditional care group received normal, standard care while hospitalized. For both care groups, infant neurobehavior, sensory processing, and parent mental health were measured at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year (corrected). Differences between the two groups were explored.
Detailed Description
Approximately 12%, or 500,000 infants, are born preterm each year in the United States alone. Although survival rates of preterm infants have increased with advances in medical care, the risk of developmental delay and disability has remained constant. Very preterm infants (<32 weeks gestation) necessitate care in the neonatal intensive care unit (NICU) for an average of three months after birth, which is a significant period of time coinciding with a critical window of brain development. While medical factors, such as brain injury, can heighten the risk of adverse neurodevelopmental outcome, the NICU environment may also have deleterious effects on early brain structure and function.
The Influence of Early Environment: Maternal deprivation and isolation from positive sensory experiences are prominent features of orphan studies. Consequences of language and human deprivation include emotional disturbances, delayed cognitive and language skills, and abnormalities evident on magnetic resonance imaging (MRI). Although the preterm infant differs from a child who has been institutionalized or deprived of caregiving attention after full term birth, there are similarities, such as the altered temporal lobe structures, and the pattern of developmental impairments. There is growing evidence supporting the importance of parents in the NICU. Low frequency visits between parents and their hospitalized preterm infants have been associated with suboptimal outcomes, like child abuse and abandonment and adverse emotional functioning. NICU's in Sweden have been successful with engaging parents in care from admission to discharge and have reported shorter hospitalizations. There is also a growing body of evidence supporting positive sensory exposures for preterm infants, including maternal voice recordings, massage, skin-to-skin holding, and vestibular and kinesthetic interventions. In addition, my team has made important research findings pointing to the potential need for developmentally-appropriate sensory exposures in the NICU.
Outcomes Associated with Preterm Birth: While advances in medical technologies have improved the rates of survival among preterm infants, the risk of long-term morbidities remains high, with 50-70% of very preterm infants exhibiting developmental problems. In addition to motor problems, language and communication problems are common in former preterm infants when studied at school age, and recent evidence suggests that language deficits persist through childhood. Language difficulties have also been shown to affect a broad range of factors important for social prowess and academic achievement. In addition, preterm infants have a heightened risk of attachment disorders and other social-emotional problems.
Outcomes Associated with Parenting a Preterm Infant: Many negative psychological sequelae are associated with parenting a preterm infant, including depression, anxiety, and post-traumatic stress. Such negative parental mental health outcomes proceed to influence the parent-child relationship, leading to a parent's inability to recognize infant cues as well as increased negativity and intrusiveness. Negative maternal-child interactions continue into the first several months of life if stress remains high. Forming such a foundation may then lead to negative child outcomes associated with social-emotional development, including attachment insecurity, and mental health issues.
Sensory Stimuli and Current Practice in the NICU: High-risk infants who receive care in the NICU are exposed to significant stressors that include painful procedures, disruption of normal sensory experiences, and stress related to parent-infant separation. In addition to the loss of parental nurturing, there is growing concern that stress during a period of extensive brain development may result in permanent and deleterious developmental outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
Parents were asked to participate in a study investigating 2 different approaches to sensory exposures in the NICU. The approach (SENSE or standard of care) were described after enrollment, based on which group they were randomized to. The evaluator was blinded to treatment assignment.
Eligibility Criteria
- Ages
- — to 32 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Preterm Infants:
- •A prospective cohort very preterm infants (VPT) born less than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis, Missouri.
- •Infant is less than or equal to 7 days old when approached about the study.
- •Parents (including emancipated minors age 12-17) of very preterm infants (VPT) born less than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis, Missouri.
Exclusion Criteria
- •Preterm Infants:
- •Known or suspected congenital anomaly, congenital infection (e.g., syphilis, HIV, TORCH), or known prenatal brain lesions (e.g., cysts or infarctions)
- •Infants that are wards of the state, or become wards of the state after enrolling in the study. Any data collected beginning at the time the state obtains custody onward will not be used in the research study.
- •Infants who are in the open ward area/bed spaces of the SLCH NICU (due to the significant variation in sensory exposure among those infants, and also to provide consistency during the hospital's impending transition to strictly private rooms in the very near future).
- •Parents with limited or no understanding of the English Language
Outcomes
Primary Outcomes
Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age
Time Frame: At term equivalent age (35-41 weeks PMA)
Infants were assessed using the NICU Network Neurobehavioral Scale (NNNS) by a blinded evaluator. The Excitability subscore, which measures state-related level of arousal over the course of the whole examination, is the primary variable of interest, and ranges from 1-8. An average response falls in the moderate, midpoint range (4-5), and describes an infant who could be brought to respond to stimuli in spite of a high degree of upset or excitement, but then can return to moderate state. Thus, a midpoint range score (4-5) would indicate a better outcome on the Excitability sub scale, whereas a lower (\<4) or higher (\>5) score would indicate a worse outcome.
Ages and Stages Questionnaire (ASQ) - Communication at 1 Year
Time Frame: One year corrected age
Parents completed the parent-report measure of child development, the Ages and Stages Questionnaire (ASQ), at 1 year corrected age. The ASQ The Communication subscore is the primary variable of interest, which looks at the child's language and communication skills at time of assessment. Higher scores on the ASQ Communication subsection indicate more positive outcomes. A child can score a minimum of 0 points and a maximum of 60 points on the Communication subscale.
Secondary Outcomes
- General Movement Assessment (GMA)(At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.)
- Parent Engagement During Hospitalization(Every day of hospitalization (from birth through discharge, often close to term equivalent age; on average about 2 months).)
- Dubowitz/Hammersmith Neonatal Neurological Evaluation(At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.)
- Mother-Infant Interaction (at 1 Year Follow-up)(One year corrected age.)
- Language Environmental Acquisition Device (LENA) Adult Word Count(Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.)
- Discharge Questionnaire(Just prior to discharge from the hospital (between 35-41 weeks post menstrual age).)
- 1 Year Follow-Up Questionnaire(One year corrected age.)
- Percentage of Sensory Interventions Received(Sensory exposures were documented every day of hospitalization (birth through discharge, often close to term) equivalent age).)
- Language Environmental Acquisition Device (LENA)(Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.)
- Sensory Exposures Provided During Hospitalization(Sensory exposures were documented every day of hospitalization (from birth to term-equivalent age; an average of about 2 months).)