Consensus definition and diagnostic criteria for neonatal encephalopathy-study protocol for a real-time modified delphi study.

BACKGROUND: 'Neonatal encephalopathy' (NE) describes a group of conditions in term infants presenting in the earliest days after birth with disturbed neurological function of cerebral origin. NE is aetiologically heterogenous; one cause is peripartum hypoxic ischaemia. Lack of uniformity in the terminology used to describe NE and its diagnostic criteria creates difficulty in the design and interpretation of research and complicates communication with families. The DEFINE study aims to use a modified Delphi approach to form a consensus definition for NE, and diagnostic criteria. METHODS: Directed by an international steering group, we will conduct a systematic review of the literature to assess the terminology used in trials of NE, and with their guidance perform an online Real-time Delphi survey to develop a consensus diagnosis and criteria for NE. A consensus meeting will be held to agree on the final terminology and criteria, and the outcome disseminated widely. DISCUSSION: A clear and consistent consensus-based definition of NE and criteria for its diagnosis, achieved by use of a modified Delphi technique, will enable more comparability of research results and improved communication among professionals and with families. IMPACT: The terms Neonatal Encephalopathy and Hypoxic Ischaemic Encephalopathy tend to be used interchangeably in the literature to describe a term newborn with signs of encephalopathy at birth. This creates difficulty in communication with families and carers, and between medical professionals and researchers, as well as creating difficulty with performance of research. The DEFINE project will use a Real-time Delphi approach to create a consensus definition for the term 'Neonatal Encephalopathy'. A definition formed by this consensus approach will be accepted and utilised by the neonatal community to improve research, outcomes, and parental experience.

Concurrent and predictive validity of the Alberta Infant Motor Scale and the Peabody Developmental Motor Scales-2 administered to infants born preterm in Norway.

BACKGROUND: The correlation between the Alberta Infant Motor Scale (AIMS) and the Peabody Developmental Motor Scales-2 (PDMS-2) has not previously been assessed in Norwegian infants. Our purpose was to investigate the concurrent validity of the AIMS and the PDMS-2 in a group of high-risk infants, and to investigate the predictive validity of the two tests for atypical motor function at 24 months post term age (PTA). METHODS: This is a retrospective study of the AIMS and the PDMS-2 administered to infants born preterm with gestational age ≤ 32 weeks (n = 139) who had participated in a randomized controlled trial of early parent-administered physiotherapy. The infants' motor development had been assessed using the AIMS and the PDMS-2 at 6- and 12-months. The primary outcome was PDMS-2 at 24-months PTA. To explore the correlation between the two tests we used Spearman's rho. Bland Altman plots were used to detect if there were systematic differences between the measurements. Receiver-operating characteristics curves were used to calculate area under the curve as an estimate of diagnostic accuracy of the AIMS and the PDMS- with respect to motor outcome at 24 months. RESULTS: The correlation between the AIMS and the PDMS-2 (total motor and locomotion subscale), at 6 months, was r = 0.44 and r = 0.76, and at 12 months r = 0.56 and r = 0.80 respectively. The predictive validity for atypical motor function at 24 months, assessed using the area under the curve at 6- and at 12- months, was for the AIMS 0.87 and 0.86, respectively, and for the PDMS-2 locomotion subscale 0.82 and 0.76 respectively. CONCLUSION: The correlation between the AIMS and the PDMS-2 locomotion subscale, at 6- and 12- months PTA, was good to excellent in a group of infants born preterm in Norway. And the AIMS and the locomotion subscale of the PDMS-2 were equally good predictors for atypical motor outcomes at 24 months PTA. These findings indicate that the AIMS and the locomotion subscale of the PDM-2, could be used interchangeable when assessing motor development in infants at 6- or 12 months of age. TRIAL REGISTRATION: ClinicalTrials.gov NCT01089296.

Test of infant motor performance: Cross-cultural adaptation, validity and reliability in Persian infants.

BACKGROUND: The Test of Infant Motor Performance (TIMP) is an appropriate tool used to measure infant motor performance in many countries and due to the importance of the TIMP in the early diagnosis of infants with developmental delay, the production of a reliable translation of the TIMP in Iran is necessary. AIMS: This study was designed to evaluate the validity and reliability of the Persian version of the TIMP and cross-cultural adaptation of the TIMP to Persian. METHOD: Twenty- two experts were involved in translation, cross-cultural adaptation, validity and reliability. 170 Persian premature infants with post menstrual age (PMA) 34-42 weeks were tested to evaluate inter-rater and intra-rater reliability, test-retest and discriminative validity of the Persian version of the TIMP. RESULTS: The content validity and face validity of the items of the Persian version of the TIMP were confirmed by a 10-expert panel and 10 therapists. High intra- and inter-rater reliability (ICC = 0.98, Kappa = 0.93), test-retest reliability (ICC = 0.98) and internal consistency (α = 0.82) were detected for the Persian version of the TIMP. Discriminative validity confirmed that the TIMP could distinguish groups of infants born with a low birth weight (p ˂ 0.001) and infants born small for gestational age (p = 0.002). CONCLUSIONS: High validity and reliability are reported for the Persian version of the TIMP and this test was demonstrated to be differentiate among groups of infants who are at risk of motor delay.

Early Identification of Atypical Motor Performance of Infants With Prenatal Opioid Exposure.

PURPOSE: To investigate the association between prenatal opioid exposure (POE) and newborn infants' motor performance to aid in the early identification of developmental delays. METHODS: Nineteen infants with POE requiring pharmacological treatment, 27 infants with POE without pharmacological treatment, and 25 infants without POE were assessed via the Test of Infant Motor Performance (TIMP). RESULTS: Infants in both groups with POE had lower TIMP scores than infants without POE. There was no difference between the TIMP scores of infants with POE who required pharmacological treatment and infants with POE who did not require pharmacological treatment. CONCLUSIONS: The TIMP can detect differences in motor performance of infants with POE. Regardless of whether infants required pharmacological treatment, POE was associated with lower motor performance. Those working in hospital or early intervention settings can use the TIMP to identify early delays in infants with POE and refer for intervention.

Two-year motor outcomes associated with the dose of NICU based physical therapy: The Noppi RCT.

BACKGROUND: Interventions involving both the parent and the preterm infant have demonstrated lasting effects on cognitive outcomes, but motor effects are less salient. It remains unclear when to commence early intervention and if dosages have impact on motor outcomes. AIMS: To examine the effect on motor performance at 24-months corrected age following a parent-administered intervention performed with infants born preterm in the NICU. Intervention dosing and longitudinal motor performance were also analyzed. STUDY DESIGN: Single-blinded randomized multicenter clinical trial. SUBJECTS: 153 infants born, gestational age ≤ 32 weeks at birth, were randomized into intervention or control group. OUTCOME MEASURES: Infant Motor Performance Screening Test, Test of Infant Motor Performance, Peabody Developmental Motor Scales-2. RESULTS: No significant difference was found between the intervention and the control group assessed with the PDMS-2 at 24-months CA. However, a significant positive association was found between dosing and the Gross Motor and Total Motor PDMS-2 scores. Analysis of longitudinal motor performance showed a decreasing motor performance between 6- and 24-months corrected age in both groups. CONCLUSIONS: There was no difference in motor performance between groups at 24-months corrected age. However, increased intervention dosage was positively associated with improved motor outcome.

Functional movement assessment with the Test of Infant Motor Performance.

The purpose of this article is to review research on the Test of Infant Motor Performance, a functional assessment of movement capabilities with age standards for infants from 34 weeks postmenstrual age through 17 weeks post term (corrected age). The Test of Infant Motor Performance was normed on a U.S. population-based sample to support its use as a tool for diagnosing delayed motor development in early infancy. The test is one of the preferred methods for parents of babies in special care nurseries to learn about their infant's development. The test was used in a variety of clinical trials to document effects of early therapy and can be used as a short-term outcome measure for other interventions expected to impact functional motor performance.

Effects of a Parent-Administered Exercise Program in the Neonatal Intensive Care Unit: Dose Does Matter-A Randomized Controlled Trial.

BACKGROUND: Despite the risk of delayed motor development in infants born preterm, knowledge about interventions in the neonatal intensive care unitt (NICU) and the effects of dosing is sparse. OBJECTIVE: The objectives of this study were to examine the effectiveness of a parent-administered exercise program in the NICU on motor outcome at 3 months corrected age (CA) and the effect of dosing on motor performance. DESIGN: This was a randomized clinical trial. SETTING: The study was conducted at 3 university hospitals in Tromsø, Trondheim, and Oslo, Norway. PARTICIPANTS: A total of 153 infants with gestational age <32 weeks at birth were randomly assigned to intervention or control groups. INTERVENTION: A 3-week parent-administered intervention designed to facilitate movements in preterm infants was performed in the NICU. Parents were asked to administer the intervention 10 minutes twice a day. MEASUREMENTS: Test of Infant Motor Performance (TIMP) was used to assess short-term outcome at 3 months CA. RESULTS: No significant difference in the TIMP z-score was found between intervention and control groups at follow-up 3 months CA, but a significant positive relationship was found between total intervention dose and TIMP z-scores. The adjusted odds of having a clinical z-score < 0 at 3 months CA was about 6 times higher for infants with less than median intervention time than for infants with a longer intervention time. LIMITATIONS: The number of infants born before 28 weeks was small. A spillover effect in favor of the control group was possible. We do not know if the infants received physical therapy after discharge from the hospital. CONCLUSIONS: There was no difference in motor performance between the intervention group and the control group at 3 months CA. However, an increased intervention dose was positively associated with improved motor outcome.

Early Parent-Administered Physical Therapy for Preterm Infants: A Randomized Controlled Trial.

OBJECTIVE: To investigate the short-term effect of parent-administered physical therapy in the preterm period on motor performance in medically stable infants. METHODS: This study was a pragmatic, multicenter, randomized controlled trial including 153 infants born at gestational age ≤32 weeks and randomized to an intervention (n = 74) or a control (n = 79) group. The intervention promoted postural control, head control, and midline orientation. Parents, supervised by a physical therapist, conducted the intervention 10 minutes twice a day for 3 weeks from 34 to 36 weeks' postmenstrual age (PMA). The control group received usual care. The Test of Infant Motor Performance Screening Items was used at baseline and the Test of Infant Motor Performance postintervention (week 37 PMA). Linear mixed models were used to assess change in motor performance between groups from 34 to 37 weeks' PMA by using z scores. Effect size was measured by using Cohen's d. RESULTS: The mean baseline z score was 0.06 (95% confidence interval, -0.48 to 0.60). After the intervention, there was a significant group difference, indicating a change in motor performance from week 34 to 37 PMA favoring the intervention group. The estimated difference in z scores was 0.42 (95% confidence interval, 0.13 to 0.72; P = .005), and the effect size was 0.40. CONCLUSIONS: Parent-administered physical therapy conducted before term-equivalent age improved motor performance at 37 weeks' PMA more than conventional care. All infants will be followed up until 2 years' corrected age to evaluate the long-term effects of this brief intervention.

Test-retest reliability of the Test of Infant Motor Performance Screening Items in infants at risk for impaired functional motor performance.

OBJECTIVE: To examine test-retest reliability of the TIMPSI in infants at risk for impaired functional motor performance. METHODS: The TIMPSI was administered twice to 51 infants from two different hospitals in Norway. RESULTS: The intra-class correlation coefficient was 0.99. CONCLUSION: Test-retest reliability of the TIMPSI was excellent.

Psychometric Properties of the Pediatric Balance Scale Using Rasch Analysis.

PURPOSE: The Pediatric Balance Scale (PBS) is a 14-item measure of functional balance for children. This study examined PBS dimensionality, rating scale function, and hierarchical properties using Rasch analysis. METHODS: The PBS data were analyzed retrospectively for 823 children, aged 2 to 13 years, with uni- and multidimensional Rasch partial credit models. RESULTS: The PBS best fits a unidimensional model based on the Bayesian information criterion analysis (12,400.73 vs 12,404.48), strong correlations between 3 proposed dimensions (r = 0.946-0.979), and high internal consistency (Cronbach α = 0.94). Analysis of rating scale functioning is limited by small numbers of children achieving low scores on easy items. Item maps indicated a ceiling effect but no substantive gaps between item difficulty estimates. CONCLUSION: The PBS items are best targeted to preschool-age children; additional children with known balance dysfunction are required to fully assess functioning of the easiest PBS items. Revisions may improve PBS utility in older children.

Behavior During Tethered Kicking in Infants With Periventricular Brain Injury.

PURPOSE: To describe behavior of children with periventricular brain injury (PBI) in a tethered-kicking intervention. METHODS: Sixteen infants with PBI were randomly assigned to exercise or no-training in a longitudinal pilot study. Frequencies of leg movements and interlimb coordination were described from videos at 2 and 4 months' corrected age (CA). RESULTS: Eight of the 13 children (62%) with longitudinal data increased the frequency of leg movements while tethered to a mobile between 2 and 4 months' CA. Movement frequency was correlated with scores on the Test of Infant Motor Performance, but no differences between experimental groups were found. Children with typical development at 12 months' CA increased the proportion of leg movements that were synchronous between 2 and 4 months, as did a child with cerebral palsy in the experimental group. CONCLUSIONS: The tethered-kicking intervention facilitates movement in infants with PBI, but effects on development remain to be demonstrated.

Correlation between fractional anisotropy and motor outcomes in one-year-old infants with periventricular brain injury.

PURPOSE: To determine whether motor outcomes of an exercise intervention beginning at 2 months corrected age (CA) in children with periventricular brain injury (PBI) are correlated with fractional anisotropy (FA) measures derived from diffusion tensor imaging (DTI) at 12 months CA. MATERIALS AND METHODS: DTI was performed in eight infants with PBI who were randomly assigned to kicking and treadmill stepping exercise or a no-training condition. Development was assessed using the Alberta Infant Motor Scale (AIMS) and the Gross Motor Function Classification System (GMFCS). FA values were derived from regions of interest (ROIs) in the middle third of the posterior limb of the internal capsule (PLIC) and the posterior thalamic radiation (PTR). RESULTS: Significant correlations were observed between motor development and FA measures. For PLIC, the correlation coefficients were 0.82 between FA and AIMS, and -0.92 between FA and GMFCS, while for PTR the corresponding correlation coefficients were 0.73 and -0.80, respectively. CONCLUSION: Results of this study suggest that quantitative evaluation of white matter tracts using DTI at 12 months CA may be useful for assessment of brain plasticity in children.

Concurrent validity of the TIMP and the Bayley III scales at 6 weeks corrected age.

PURPOSE: Examine agreement between the Test of Infant Motor Performance (TIMP) and the Bayley III. METHODS: One hundred forty-five infants born at 29 to 34 weeks gestation with socioenvironmental risk factors were tested on the TIMP and Bayley III at 6 weeks corrected age (CA). Scores were correlated to assess convergence/divergence of content. Decision analysis using a cutoff of the mean on the Bayley Motor Composite and -0.5 and -1 SD from the mean on the TIMP assessed agreement on delay/nondelay. RESULTS: The TIMP-Bayley Motor Composite correlation was 0.546, with Cognitive was 0.310, and with Language was 0.281. Nine percent of infants scored less than -1.0 SD on the TIMP, while no child scored less than -1 SD on the Bayley Motor scale (sensitivity, 31%). CONCLUSIONS: Convergent validity between the TIMP and the Bayley Motor scale was demonstrated, but no infant showed delay on any Bayley scale. The TIMP is preferred for early assessment of infants.

Physical therapy observation and assessment in the neonatal intensive care unit.

This article presents the elements of the Observation and Assessment section of the Infant Care Path for Physical Therapy in the Neonatal Intensive Care Unit (NICU). The types of physical therapy assessments presented in this path are evidence-based and the suggested timing of these assessments is primarily based on practice knowledge from expert therapists, with supporting evidence cited. Assessment in the NICU begins with a thorough review of the health care record. Assessment proceeds by using the least invasive methods of gathering the behavioral, developmental, physiologic, and musculoskeletal information needed to implement a physical therapy plan of care. As the neonate matures and can better tolerate handling, assessment methods include lengthier standardized tests with the psychometric properties needed for informing diagnosis and intervention planning. Standardized tests and measures for screening, diagnosis, and developmental assessment are appraised and special considerations for assessment of neonates in the NICU are discussed.

Use of care paths to improve patient management.

The purpose of this special issue of Physical & Occupational Therapy in Pediatrics is to present an evidence-based system to guide the physical therapy management of patients in the Neonatal Intensive Care Unit (NICU). Two systematic guides to patient management will be presented. The first is a care path intended primarily for use by physical therapists, and the second is a care path for families of infants being cared for in the NICU. In this article, background information on the concept of using care paths for clinical management is presented, followed by a general description of the two care paths for use in the NICU. Subsequent articles describe physical therapy practice in the context of the NICU team approach to care for medically fragile infants with more detail on use of the two care paths and the evidence supporting their contents.

Effects on motor development of kicking and stepping exercise in preterm infants with periventricular brain injury: a pilot study.

BACKGROUND: Preterm infants with periventricular brain injury (PBI) have a high incidence of atypical development and leg movements. OBJECTIVE: Determine whether kicking and treadmill stepping intervention beginning at 2 months corrected age (CA) in children with PBI improves motor function at 12 months CA when compared with control subjects. METHOD: In a multi-center pilot study for a controlled clinical trial, sixteen infants with PBI were randomly assigned to home exercise consisting of kicking and treadmill stepping or a no-training control condition. Development was assessed at 2, 4, 6, 10, and 12 months CA with the Alberta Infant Motor Scale (AIMS). At 12 months children were classified as normal, delayed, or with cerebral palsy (CP). RESULTS: At 12 months CA 3 of 7 (43%) of the exercise group children walked alone or with one hand held versus 1 of 9 (11%) in the control group (p=0.262), but no significant differences in AIMS scores were found at any age. Half of the subjects had CP or delay; the outcomes of these infants were not improved by exercise. Compliance with the home program was lower than requested and may have affected results. CONCLUSION: Although not statistically significant with a small sample size, self-produced kicking and treadmill exercise may lower age at walking in infants with normal development following PBI, but improvements of the protocol to increase and document compliance are needed before a larger study is implemented.

Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences.

BACKGROUND: Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy. METHODS/DESIGN: A pragmatic randomized controlled study has been designed to assess the effect of a preventative physiotherapy program carried out in the neonatal intensive care unit. Moreover, a qualitative study is carried out to assess the physiotherapy performance and parents' experiences with the intervention. The aim of the physiotherapy program is to improve motor development i.e. postural control and selective movements in these infants. 150 infants will be included and randomized to either intervention or standard follow-up. The infants in the intervention group will be given specific stimulation to facilitate movements based on the individual infant's development, behavior and needs. The physiotherapist teaches the parents how to do the intervention and the parents receive a booklet with photos and descriptions of the intervention. Intervention is carried out twice a day for three weeks (week 34, 35, 36 postmenstrual age). Standardized tests are carried out at baseline, term age and at three, six, 12 and 24 months corrected age. In addition eight triads (infant, parent and physiotherapist) are observed and videotaped in four clinical encounters each to assess the process of physiotherapy performance. The parents are also interviewed on their experiences with the intervention and how it influences on the parent-child relationship. Eight parents from the follow up group are interviewed about their experience. The interviews are performed according to the same schedule as the standardized measurements. Primary outcome is at two years corrected age. DISCUSSION: The paper presents the protocol for a randomized controlled trial designed to study the effect of physiotherapy to preterm infants at neonatal intensive care units. It also studies physiotherapy performance and the parent's experiences with the intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT01089296.