Early Intervention Post-Hospital Discharge for Infants Born Preterm

highlights the findings and application of Cochrane reviews and other evidence pertinent to the practice of physical therapy. The Cochrane Library is a respected source of reliable evidence related to health care. Cochrane systematic reviews explore the evidence for and against the effectiveness and appropriateness of interventions—medications, surgery, education, nutrition, exercise—and the evidence for and against the use of diagnostic tests for specific conditions. Cochrane reviews are designed to facilitate the decisions of clinicians, patients, and others in health care by providing a careful review and interpretation of research studies published in the scientific literature.1Each article in thisPTJseries summarizes a Cochrane review or other scientific evidence resource on a single topic and presents clinical scenarios based on real patients to illustrate how the results of the review can be used to directly inform clinical decisions. This article focuses on early intervention programs after hospital discharge for preterm infants.Can interventions with a focus on parent-infant relationships improve motor and cognitive outcomes in infants born prematurely? Worldwide, an estimated 15 million infants are born preterm (<37 weeks' gestational age) every year; over the past 2 decades, the rate of premature birth has increased in almost all countries with reliable data.2 Infants born preterm or with low birth weight are at increased risk of death, organ complications (eg, infections, chronic kidney disease, bronchopulmonary dysplasia), neurological impairments (eg, periventricular leukomalacia, intraventricular hemorrhage, cerebral palsy, developmental coordination disorder), visual impairments (eg, retinopathy of prematurity), hearing impairments (affecting language development), cognitive impairments (eg, short-term memory deficits, learning disabilities), and psychiatric impairments (eg, attention deficits, autism spectrum disorder).3–5 The impact of preterm births not only affects the child and family, but also places a large cost on health care systems. Indeed, even infants born late preterm (33–36 weeks) can incur almost twice the expense of a term birth in the first 2 years of life6 and account for one-quarter of the cost of all pediatric hospitalizations in the United States.7 With medical advances such as the use of surfactant improving the survivability of this population, interventions to prevent or reduce the functional impact of these impairments later in life have been investigated increasingly.8 It has been suggested that interventions provided early in life can enhance an individual's potential, as plasticity is greatest in the developing brain during this time.9–11 Early intervention for infants at risk for neurodevelopmental delay due to prematurity extends across many disciplines and differs according to an infant's needs, services available, and family considerations. Programs implemented after hospital discharge are able to focus on the infant's development, on the home and supporting community environment, and on the relationships between infant and parents. Physical therapy interventions may have a primary motor focus, but therapists are encouraged to consider all aspects of a child's functioning to meet goals in a collaborative, family-centered manner.12,13 For example, motor abilities play an integral part in cognitive development through exploration of environment and interaction with others, and physical therapy intervention can affect global development through early perceptual-motor experiences.14 Early developmental intervention programs differ widely in aim, focus, type, and primary service provider; however, they share a common goal of preventing or reducing the functional impact of impairments. Spittle and colleagues15 conducted a Cochrane systematic review to investigate the overall effectiveness of early developmental intervention programs after hospital discharge for infants born preterm. They reviewed the evidence for motor and cognitive outcomes at infant age (birth to <3 years), preschool age (3 to <5 years), and school age (5 to <18 years). Furthermore, they conducted a subgroup analysis to compare the effectiveness of early intervention programs with a focus on infant development only, parent-infant relationship only, or combined (infant development and parent-infant relationship). Spittle et al15 searched electronic databases initially in August 2011 and updated their search in October 2012. The authors included randomized controlled trials (RCTs) or quasi-RCTs that compared early developmental intervention programs with standard care, and they examined motor or cognitive outcomes for infants born <37 weeks' gestational age. Interventions had to begin within the first 12 months' post-term age and could be provided in any setting by any health care professional. Spittle and colleagues15 initially identified 16 studies from their August 2011 search that met their inclusion criteria and an additional 5 studies from their updated search in October 2012. They assessed each study for risk of bias according to the Cochrane Collaboration's tool for assessing risk of bias.16 There were 16 RCTs, 4 quasi-RCTs, and 1 cluster RCT. Only 9 of the included studies adequately concealed treatment allocation, and almost all trials were at high risk of performance bias due to lack of blinding of participants, parents, and therapists. Almost all studies had at least 1 blinded outcome assessment. Risk of attrition bias (dropouts, incomplete data) also was high or unclear in 13 of the 21 studies. Overall, data were collected on 3,133 participants born at <37 weeks or <2,500 g, or both. Six studies included interventions provided by a physical therapist, 6 included interventions provided by a nurse, and 9 included interventions provided by other health care professionals (eg, physician, psychologist). Interventions included various foci: education of parents on infant development and milestones, understanding of behavioral cues; infant stimulation, physical therapy, occupational therapy, early educational intervention, and parent-infant relationships. Importantly, standard or usual care also varied between and within trials; control groups were not prevented from accessing services such as physical therapy, speech-language therapy, hospital discharge education, or standard medical follow-up as deemed necessary and ethical by their health care teams. This is an important consideration, as control groups receiving services may mask the treatment effect size of the intervention groups. Motor and cognitive outcomes were assessed with standardized measures at varying ages in the trials (Tab. 1); effect sizes were compared with meta-analysis using standardized mean differences.15 A small significant effect was found in favor of the intervention group for motor outcomes at the infant age only (effect size=0.10; 95% confidence interval [95% CI]=0.00, 0.19; P=.04). Using the Psychomotor Developmental Index of the 3 editions of the Bayley Scales of Infant Development (BSID) as an example (the motor outcome measure used in 13 of the 17 studies included in the meta-analysis), this effect would translate clinically into a mean between-group difference of just 1.5 points (each of the BSID editions use mental and motor developmental indexes with a mean of 100 and a standard deviation of 15). Significant medium-sized effects were found in favor of the intervention group for cognitive outcomes at infant age (effect size=0.31; 95% CI=0.13, 0.50; P<.001) and preschool age (effect size=0.45; 95% CI=0.34, 0.57; P<.001). With the Mental Developmental Index of the BSID used as the cognitive outcome for 13 of the 18 infant studies, this finding means that the intervention groups scored an average of 4.65 points higher than the standard care groups. At preschool age, 4 of the 6 studies used cognitive outcome measures, each with a mean of 100 and a standard deviation of 15; consequently, the preschool-aged children who received intervention scored 6.75 points higher, on average, than preschoolers in standard care. The rate of cerebral palsy in control and intervention groups was examined in 5 studies; meta-analysis determined no significant difference of the risk ratio between groups (risk ratio=0.89; 95% CI=0.55, 1.44; P=.64). Summary of Key Results of Review by Spittle et al15,a PDI for BSID-I or BSID-II BSID-III Griffiths Locomotor Subscale Test of Infant Motor Performance (TIMP) Alberta Infant Motor Scale (AIMS) PEDI Movement ABC McCarthy Scales of Children’s Abilities (motor scales) Rate of cerebral palsy MDI for BSID-I or BSID-II Griffiths Mental Development Scale Stanford-Binet Intelligence Scale McCarthy Scales of Children’s Abilities WASI WISC-III WPPSI Kaufman Assessment Battery for Children British Ability Scale PDI for BSID-I or BSID-II BSID-III Griffiths Locomotor Subscale Test of Infant Motor Performance (TIMP) Alberta Infant Motor Scale (AIMS) PEDI Movement ABC McCarthy Scales of Children’s Abilities (motor scales) Rate of cerebral palsy MDI for BSID-I or BSID-II Griffiths Mental Development Scale Stanford-Binet Intelligence Scale McCarthy Scales of Children’s Abilities WASI WISC-III WPPSI Kaufman Assessment Battery for Children British Ability Scale BSID=Bayley Scales of Infant Development, ID=infant development, MDI=Mental Developmental Index, PDI=Psychomotor Developmental Index, PIR=parent-infant relationship, PIRID=parent-infant relationship and infant development, PVL=periventricular leukomalacia, N=number of participants, NE=number of participants in experimental group, RCT=randomized controlled trial, WASI=Wechsler Abbreviated Scale of Intelligence, WISC-III=Wechsler Intelligence Scale for Children–Full-Scale IQ test, WPPSI=Wechsler Preschool and Primary Scale of Intelligence. *P=.04, **P<.001, ***P=.02, ****P<.0001. Effect size reported as standardized mean differences: 0.2=small, 0.5=medium, 0.8=large. Summary of Key Results of Review by Spittle et al15,a PDI for BSID-I or BSID-II BSID-III Griffiths Locomotor Subscale Test of Infant Motor Performance (TIMP) Alberta Infant Motor Scale (AIMS) PEDI Movement ABC McCarthy Scales of Children’s Abilities (motor scales) Rate of cerebral palsy MDI for BSID-I or BSID-II Griffiths Mental Development Scale Stanford-Binet Intelligence Scale McCarthy Scales of Children’s Abilities WASI WISC-III WPPSI Kaufman Assessment Battery for Children British Ability Scale PDI for BSID-I or BSID-II BSID-III Griffiths Locomotor Subscale Test of Infant Motor Performance (TIMP) Alberta Infant Motor Scale (AIMS) PEDI Movement ABC McCarthy Scales of Children’s Abilities (motor scales) Rate of cerebral palsy MDI for BSID-I or BSID-II Griffiths Mental Development Scale Stanford-Binet Intelligence Scale McCarthy Scales of Children’s Abilities WASI WISC-III WPPSI Kaufman Assessment Battery for Children British Ability Scale BSID=Bayley Scales of Infant Development, ID=infant development, MDI=Mental Developmental Index, PDI=Psychomotor Developmental Index, PIR=parent-infant relationship, PIRID=parent-infant relationship and infant development, PVL=periventricular leukomalacia, N=number of participants, NE=number of participants in experimental group, RCT=randomized controlled trial, WASI=Wechsler Abbreviated Scale of Intelligence, WISC-III=Wechsler Intelligence Scale for Children–Full-Scale IQ test, WPPSI=Wechsler Preschool and Primary Scale of Intelligence. *P=.04, **P<.001, ***P=.02, ****P<.0001. Effect size reported as standardized mean differences: 0.2=small, 0.5=medium, 0.8=large. A subgroup meta-analysis comparing interventions based on their focus (infant development only, parent-infant relationship only, combined) was performed using standardized mean differences. Significant effects were found favoring combined interventions on cognitive outcomes at infant age (effect size=0.24; 95% CI=0.04, 0.43; P=.02) and preschool age (effect size=0.47; 95% CI=0.36, 0.59; P<.0001) ages. Because all of these studies used 1 of the 3 BSID editions as an outcome measure, the mean difference in Mental Developmental Index in favor of the combined interventions would be 3.6 points in infants and 5.4 points in preschoolers. Based on 1 trial using the BSID-II as the outcome measure, a significant effect also was found on cognitive outcomes for interventions focusing on parent-infant relationship only at infant age (effect size=0.73; 95% CI=0.11, 1.36; P=.02), thus yielding a mean difference in favor of parent-infant relationship focus of 10.95 points. Interventions focusing on infant development only did not demonstrate any significant effects on motor or cognitive outcomes. Although the Cochrane review showed positive effects from early developmental intervention programs on cognitive development of infants born preterm and a smaller impact on their motor outcomes in the short term, these data should be interpreted cautiously. As Spittle and colleagues15 pointed out, the variability in the interventions received by the active treatment groups was heterogeneous, and high risk of performance bias in most studies (as well as other methodological shortcomings) may have overestimated any treatment benefit. Interventions do not appear to be able to prevent motor impairments such as cerebral palsy in this population but may be able to affect the functional consequences of the neurological disorder. Interventions focusing on both infant development and the parent-infant relationship have the greatest impact on cognitive development of infants born preterm. Furthermore, it is unclear to what extent the statistically significant differences are clinically meaningful. Effect sizes calculated in this meta-analysis were largely dependent on the various BSID editions and subscales. Although the BSID is standardized, with established reliability and validity, no minimal clinically important difference has yet been established for any of the versions. This Cochrane review did not address other outcomes that may be influenced by early developmental intervention programs, such as behavior, activity or participation levels, or parental functioning. Intervention parameters such as frequency, duration, and adherence also were not analyzed in this review. A summary of key results is presented in Table 1. “Monica” was born at 32 weeks' gestation and remained in the neonatal intensive care unit (NICU) of her local hospital until she was 2 months' corrected age. The NICU discharge plan included a referral for Monica to her local early intervention therapy (EIT) program, with primary concerns of motor delay based on a score that was 2 standard deviations below the mean on the Test of Infant Motor Performance Screening Items (TIMPSI).17 A physical therapist initially assessed Monica's health status in her home at 2.5 months' corrected age using the International Classification of Functioning, Disability and Health (ICF) to structure the examination (Tab. 2).18 Monica's parents expressed concern that she was not doing things that other babies they knew in their community were doing. They want her to be able to keep up with other children academically when she goes to school and for her to be able to run and play like them. At the time of assessment, an identified strength was Monica's ability to suck and swallow infant formula from a bottle. She appeared to enjoy participating in her feeding routine, as evidenced by her smiles and alert facial expressions. Relevant Information From Monica’s Initial ICF Assessment at 2.5 Months’ Corrected Agea ESL=English as a second language, ICF=International Classification of Functioning, Disability and Health, OT=occupational therapist, SD=standard deviations, SLP=speech-language pathologist, TIMP=Test of Infant Motor Performance. Relevant Information From Monica’s Initial ICF Assessment at 2.5 Months’ Corrected Agea ESL=English as a second language, ICF=International Classification of Functioning, Disability and Health, OT=occupational therapist, SD=standard deviations, SLP=speech-language pathologist, TIMP=Test of Infant Motor Performance. Monica's activity limitations (and strengths) were assessed with the Test of Infant Motor Performance (TIMP).19 Her TIMP score was −2.37 standard deviations. Monica's activity strengths and limitations included: (1) difficulty maintaining her head at midline in the supine position, with inability to turn her head past midline to the left when presented with a bright red ball; (2) good head righting into extension in the prone position but limited head control in supported sitting and when pulled to sit (inadequate head righting into flexion); (3) inability to roll past midline when rolling was facilitated from either the arm or the leg when positioned supine; and (4) ability to lie on her stomach on her but limited ability to turn her head in this Monica structure and periventricular on evidence from a in both of of her left overall and limited motor for included Monica's age, her her for through and and her for by her also were in assessing Monica's health Monica was born to parents, and she was their first They in a small home with the and had other family in the Monica's health care services included follow-up of her neonatal follow-up at ages 18 and 3 and the physical therapy was and Monica was on a for speech-language therapy and occupational therapy The physical therapist with a speech-language and an occupational therapist until Monica was to their and the physical therapist the primary goal that Monica would be able to keep up with her in school by the time she Furthermore, the physical therapist Monica's motor and cognitive development would from a family-centered to early intervention that the relationships the The was focusing on both infant development and parent-infant relationships than just infant development and improve motor and cognitive outcomes in an infant born at 32 weeks' gestational The reviewed the provided in the systematic review by Spittle et al15 and determined that the parameters were and to this Monica's age and health status the population examined in the infants born preterm with intervention 12 of age. however, only 2 of the 21 studies included in the Cochrane periventricular as an inclusion Monica's parents had expressed that motor and play with and cognitive up were important goals for their family, and these were the primary outcomes of Spittle and The systematic review provided evidence for the physical therapist Monica that using time and to address parent-infant relationships as well as motor and concerns could to address this goals for Monica in both motor and cognitive of the TIMP for of this infant was this was found in the study by and (1) children at hospital discharge who could from intervention and (2) be to the effects of a physical therapy home from discharge to 4 months' corrected age) on an infant's motor are for infants up to 4 months' corrected age for use in delay in preterm infants such as The TIMP also was in 2 studies to be a for parents to the development of their premature with the family and other the physical therapist established the care The therapist initially home every the to every 3 to 4 weeks as parents with a home suggested during play and time as well as within were on how to a for Monica to her in all of for providing included physical and positive and and The therapist the parents to for that Monica a (eg, her and or that she was for even of (eg, to on specific goals for each Based on the of the to early the parents were to play and into their and on developmental play the of the care the physical therapist all 3 of research the systematic review by Spittle et the clinical family-centered in and the and of Monica's family motor and cognitive others in the by the physical therapist on providing education to the parents on infant development, and to infant for feeding and play (eg, prone on in setting up and (eg, and using positive behavioral (eg, using setting and as Monica The therapist encouraged the family to use in their first language and (eg, to positive with the therapist provided community and for community (eg, play the parents to meet other with infants and and in home on an as Monica and with to the Because Monica's parents expressed in using the therapist encouraged and to use it as a positive with their Monica to physical therapy, speech-language therapy, and occupational therapy her infant and preschool services were provided within her in her and in community (eg, Spittle et al15 that early intervention may have an impact on functional and even physical outcomes do not They the of assessing abilities in their from a For these the physical therapist goal as an outcome is an measure of that can be to various such as or and is for use with and (as within this physical intervention The therapist had in setting and measures, reducing the of bias in the use of this With from the family and other goals were and reviewed every 6 Because of Monica's her parents were that her functional would be that visual of a was a cognitive (as well as for infants the therapist a measure at Monica's visual an activity that her parents could with Monica at home 3 for the measure of visual for a for Monica for a for Monica Monica's TIMP score at 4 corrected age was standard deviations from the Based on of the TIMP at 3 months' corrected this score could be to motor performance up to school age, was the as Monica's Alberta Infant Motor performance at 12 months' corrected age was below average at standard deviations and she to motor performance at school age. with the results of and of intervention for Monica in the early of life her TIMP motor performance from standard deviations below the mean to standard deviation at 4 months' corrected age. As the Cochrane review early intervention did not prevent Monica from receiving a of cerebral she to demonstrate in her and at 18 months' corrected age, she received a of however, the goals in both motor and cognitive (eg, and to for her by her parents, the physical therapist, and other Monica was by months' corrected age, her in of the Motor Classification Monica the of on the and was able to run and with by at age 5 she to and and she limitations in compared with her At Monica almost and language and knew most of the She learning and from and for motor such as using her at Monica to with other Monica's parents were able to for Monica's and they knew how to services as The findings of this Cochrane review can be to infants born <37 weeks' gestational age who have been from the hospital medical complications such as the for and or The findings are to infants born preterm with the of periventricular or cerebral palsy, as infants with these impairments were not from the trials included in the review. Early of for this intervention is the age at participants in the reported studies receiving services and that plasticity may be greatest early in for early developmental intervention with a focus on both infant development and parent-infant relationships therapist and and as well as the and This systematic review developmental early intervention programs after hospital discharge for infants born preterm and was limited by the of intervention by the high risk of and attrition across studies, and by the services provided to the control groups within Spittle and colleagues15 that is evidence for early intervention programs to affect cognitive outcomes at infant and preschool ages and to have a small effect on motor outcomes at infant age. Interventions at an infant development focus with parent-infant relationships were found to have a impact on cognitive development, supporting a family-centered to early intervention Although early intervention programs are not to affect of cerebral palsy in infants born functional in cognitive and motor can be a

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