Current Research Studies

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Developmental Care Study

Fetal growth restriction (FGR) increases the already substantial risk of prematurity for infants' survival, overall function and later learning competence. Of the 12% of prematurely born infants in the US each year, more than 5% failed to grow appropriately in the womb due to placental insufficiency. 

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These infants present immediate significant challenges to Newborn Intensive Care Units (NICU); more than 70% will go on to develop learning disabilities and require special educational services. It is postulated that the NICU's stressful environment may exacerbate the FGR infant's low threshold of reactivity and jeopardize already compromised brain development. The proposed project will test the effectiveness of an in-NICU intervention for such infants. It will consist of efforts to individualize all care to the infant's thresholds of sensitivity and to thereby improve neural fiber tract development (MRI) and neurophysiologic functioning (EEG). This in turn is expected to result in better behavioral adaptations. Thirty FGR preterm infants will be randomized to either a Developmental Care (E) or Standard Care (C) group. All infants will be studied within 7 days of birth (baseline) and again at 2 weeks corrected age (2w CA) (outcome). The FGR-E group is expected to show better development at 2w CA in the 3 domains to be tested, neurobehavior, electrophysiology, and brain structure. Furthermore, the FGR infants will be compared to a sample of appropriate in growth for gestational age (AGA) preterm infants for whom comparable data are available at both age points from a previous study. The FGR and AGA C and E groups will be compared in order to identify sample specific aspects of the intervention effects. This might lead to better understanding of the intervention's interaction with sample specific risk factors. Results are expected to show brain-based effects of the intervention for the FGR infants, mediated by stress reduction. This is expected to bring them closer in functioning and brain structural development to their AGA peers. The study will be significant in understanding ways to reduce long-term functional morbidities in FGR infants, as well as in identifying opportunities for enhancing last trimester brain development.

Goals of the Study

The purpose of this study is to learn more about the development of prematurely born infants who at birth are small for their age. We are interested in finding out whether reading the infants' behavioral cues may be helpful in structuring and adapting the care and the environment in the nursery to be specifically responsive to the infant in helping the infant be restful, build on the infant's strengths and reduce stress as much as feasible. We anticipate that such close attention to the infant's behavioral cues may have a positive effect on the infant's later brain development and learning.

Who Will Participate?

It is our aim to enroll in our study thirty families and their prematurely born infants who at birth are small for their age. Eligible to participate in our study are infants who are born between 24 and 34 weeks gestation. Once the family agrees an infant will be randomly assigned to one of two groups, namely either to the group which receives the best standard care in the nursery or to the group which receives additional weekly detailed observations of their behavior. The observations will be used in planning the infant's care and adjusting their environment to be specifically supportive to them.

What is involved in Participation?

All study infants will participate in two sets of evaluations. The first set takes place in the NICU soon after the infant's birth, and the second set of evaluations occurs at 2 weeks after the infant's expected due date. By then the infant will most likely no longer in the NICU and therefore for this second appointment we make arrangements the infant and family to Boston Children's Hospital for the study. Each set of evaluations has three parts: (1) A behavioral assessment; (2) An EEG of the brain; and (3) an MRI scan of the brain. In addition, we ask the parents questions about their infant's health and well-being, likes and dislikes and the family's wellbeing.

What is a Behavioral Assessment?

The behavioral assessment consists of observation of the infant when sleeping; assessment of the infant's preferred position; whether the infant will shut out repeated lights from a flashlight and sounds from a soft rattle; and what strategies help best console the infant when he or she is crying. We will also test the infant's strengths of movements and reflexes. This examination, the Assessment of Preterm Infants' Behavior (APIB), is commonly performed in many medical facilities. The assessment takes approximately an hour. In addition, we weigh the infant and measure the infant's length and head circumference.

What is an EEG?

An EEG (electroencephalogram) is a routinely used, noninvasive clinical procedure that is widely used to record brain wave activity. Our experienced EEG technologist places a small mesh cap outfitted with tiny sensors (electrodes) on the infant's head in order to record this information. The infant does not receive any sedation, medications, injections or other substances during the EEG. The infant will be held by the behavioral specialist throughout.

What is an MRI?

MRI stands for Magnetic Resonance Imaging, which also is a completely noninvasive clinical method. It does not involve any exposure to radiation, medication, or X-Rays. The MRI scanner uses the brain's naturally produced magnetic energy to make pictures of the brain. These pictures show how the infant's brain develops. While the infant is sleeping in the scanner, his or her heart rate and blood oxygen levels are monitored at all times.

What are the Benefits of Participating?

We hope that this study will lead to better understanding and treatment of future infants, who have to overcome problems related to an early birth. Every infant receives a behavioral evaluation, an EEG and MRI of the brain, free of charge. Parents have the opportunity to participate in their child's evaluations and learn about their child's strengths. Any unusual unexpected findings are reported to the parents and the child's pediatrician. We reimburse participants for their time commitment and all expenses connected with the study.

This study is funded by the National Institute of Health (NIH), Washington, DC.

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Does Early Experience Improve Preterm Neurodevelopment?

About fifty percent of prematurely born infants develop learning/behavior problems and school failure. The study will test the primary hypotheses, that preterm infants (PT) randomized to developmental care in the Newborn Intensive Care Unit (NICU) will be superior in cognitive performance at school age when compared to their peers, who did not receive the intervention. 

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Fifty-two [26 control (C); 26 experimental (E)] infants born at a gestational age (GA) of 28-33 weeks (w) will be studied at 8 years (y) corrected age (CA). Three secondary hypotheses will be tested: The PT-E group will be superior to the PT-C, 1) in academic performance; 2) in long distance cortical connectivity of frontal and occipital brain systems (EEG coherence), and 3) in frontal cortical white matter volumes (MRI). Child physical and psychosocial functioning will be explored descriptively. The primary independent variable will be treatment group (PT-control, PT-experimental). Additionally tested will be GA, growth percentile (weight and head circumference) at birth, parent socioeconomic status, and parent cognitive function, all expected to influence outcome. The PT sample will be described by previously collected medical and demographic measures at birth, and by behavior and brain function at 2wCA and 9mCA. The study will provide, for the first time, evidence at school age of the effectiveness of a much needed, low cost, early behavioral intervention. The expected reduction in learning and school failure for the increasing numbers of preterm-born children in the nation's schools, would give the study and the intervention, significant national public health importance.

Goals of the Study

The purpose of this study is to investigate the long-term outcome of developmental care in the Newborn Intensive Care Unit (NICU). The goal of this study is to assess the functioning of the preterm born children from teh study as they reach school age in order to see if our developmental care intervention is effective in the long term.

Who Will Participate?

It is our aim to enroll in our study fifty-two families and their prematurely born children. All children previously participated in our research study as infants in the NICU at the Brigham and Women's Hospital and are now between 6-10 years old. Approximately half of the children were small for their age at birth and the other half weighed an appropriate amount given their age. We studied all children when they were 2 weeks old and then again when they were 9 months old, counted from teh date that their parents had expected them to be born. Some of the children were studied again at 2 years and 3 years after expected term due date.

What is Involved in Participation in the Study?

All study children will participate in a three part evaluation that takes place at Boston Children's Hospital. Each evaluation includes (1) a behavioral assessment; (2) an EEG of the brain; and (3) an MRI scan of the brain. In addition, there are parental interviews and questionnaires about the child's behavior, health and well-being. The behavioral assessment consists of an evaluation of the child's intellectual abilities, academic skills, motor skills, and physical and social-emotional functioning. These areas are assessed through a battery of standardized tests.

What are the Benefits of Participating?

We hope that this study will lead to better understanding of the development and treatment of future preterm born children. Each child receives a neuropsychological evaluation, an EEG and an MRI of the brain, free of charge. Parents have the opportunity to particpate in their child's evaluations and learn about their child's strengths. Any clinically relevant unexpected findings are reported to the child's parents and pediatrician, and we make every effort to help parents identify and obtain the appropriate resources for their child. Families are reimbursed for all expenses connected with the study and receive a stipend for their time commitment.

This study is funded by the National Institute of Health (NIH), Washington, DC.

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Adolescents Born Preterm: Nurtured Beginnings

The goal of this research project is to identify the effectiveness of earliest nurturing intervention in the newborn intensive care unit (NICU) in improving the health and neurodevelopmental functioning of adolescents born preterm and at high risk for later disabilities. According to the literature more than 50% of this population will be impaired in central mental control functions required for all learning and social adaptation, aside from frequent focal impairments of cerebral palsy and sensory deficits. 

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Disadvantaged homes, poverty, and poor education worsens outcome. The proposed longitudinal randomized controlled trial will study in adolescence, 14-21 years corrected age (CA), 107 very early born (<28w gestation) infants, who were previously studied at 2 weeks and 9 months CA. The control group (n=51) received traditional NICU care, while the experimental group (n=56) received nurturing developmental care in the form of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP). The primary adolescent outcome measures will be neuromedical wellbeing and mental function, with emphasis on mental control, academic achievement, and social-emotional adaptation. Secondary mediating measures will be parenting function, and the adolescents' educational experience. This is the first randomized controlled trial of the long-term effectiveness of earliest nurturing in-NICU intervention.

Goals of the Study

The purpose of this study is to test continued long-term intervention effectiveness of very early born preterm infants, who participated in a randomized Newborn Individualized Developmental Care and Assessment Program (NIDCAP) trial, conducted by the principal investigator, while the infants were cared for in the NICU for the first three months after their very premature births. The goal is to assess the functioning of the preterm born children from the study as they are adolescents in order to see if our developmental care intervention is effective in the long term.

Who Will Participate?

Adolescents age 16-21 years who participated as newborns in a study in the NICU and were assigned either to control care (standard NICU care available at the time), or to experimental care (NIDCAP developmental care, with weekly bedside observations and with daily NIDCAP developmental specialist support to parents and staff), from NICU admission until 2 weeks after expected fullterm due date (corrected age (CA)).

All the adolescents to be studied were evaluated comprehensively at 2wCA and 9 months CA in terms of not only the commonly measured demographic, medical background and severity of illness variables, but more importantly in terms of comprehensive neurobehavioral and EEG outcome measures, analogues of later developmental competence and disability.

What is Involved in Participation in the Study?

The study takes place at Boston Children's Hospital and involves a neuropsychological assessment of the child and a parent interview/questionnaire. The neuropsychological evaluation consists of a battery of standardized tests that assess intellectual abilities, academic skills, and social-emotional functioning.

What are the Benefits of Participating?

We hope that this study will lead to better understanding of the development and treatment of future preterm born children. Specifically, we are looking to examine group effects (control and experimental) on adolescent physical growth and cognitive development. In addition to group status, the contribution of four additional measures will also be evaluated: Parent socio-economic status, parent cognitive function, adolescent physical function and adolescent psychosocial function. All participants receive a free neuropsychological evaluation and relevant feedback.

This study provides a unique opportunity to evaluate comprehensively in adolescents the long-term neurodevelopment, learning and adaptive outcomes due to developmental care intervention received in the earliest stage of development. This will be the first study to test the long-term effectiveness of modification of experience in the NICU in a brain-protective, learning-enhancing model for very high-risk, very early-born preterm infants. The importance of the study lies in its potential to contribute significantly to the understanding of preterm brain development in relationship to long-term mental and adaptive functional outcomes in adolescence for the highly jeopardized and growing group of very preterm children. The results are expected to be of key importance in decision and policy development for the evidence-based targeting of sparse special education resources. All participants are compensated for their time adn for all expenses connected with the study.

This study is funded by the United States Department of Education.

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