40 Clinical Trials for Various Conditions
To determine if 3 randomly assigned bundles of stewardship interventions would reduce overall and inappropriate antimicrobial use in the neonatal intensive care unit (NICU), a pre-post study was performed in 4 NICUs.
Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dybiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.
The purpose of this study is to assess the accuracy of FEEDBACK for measuring breastmilk intake of a pre-term baby. Mothers and babies will use the FEEDBACK system during a breastfeeding session in the NICU. Babies will be weighed prior to breastfeeding and again after breastfeeding. The weight gain of the baby will be compared to the volume measured using FEEDBACK. The study will also evaluate the device safety and ease of use.
The investigators hypothesized that an enriched focus on mother-infant bonding during a newborn's hospitalization in the Neonatal Intensive Care Unit would reduced the rate maternal postpartum smoking relapse and would prolong the duration of breastfeeding in mothers who had quit smoking during or just prior to pregnancy.
Infants born premature face numerous medical problems, causing significant anxiety for their parents. Parents experience a range of negative emotions including concern for the health and well being of their fragile infant, guilt, and disappointment. Research has indicated that having an infant in the Neonatal Intensive Care Unit (NICU) is highly stressful for parents and multiple studies have demonstrated that parents can develop significant psychological reactions to this experience. Specifically, many parents develop clinically significant anxiety disorders such as acute stress disorder (ASD) and posttraumatic stress disorder (PTSD). This not only impacts the mental well-being of the parents, but also can lead to problems with the parent-infant relationship, and, in turn, negatively impact the infant and the family as a whole. Despite the reported negative effects parents experience due to the stress of having an infant on the NICU, surprisingly little research has examined how to reduce parents' symptoms of anxiety. Because parents play an essential role in the care of their infant after discharge from the NICU, treating the parent's emotional distress is highly important. The purpose of this study is to examine the efficacy of a cognitive-behaviorally based intervention in reducing parents' symptoms of anxiety associated with having an infant on the NICU. This treatment is modeled after treatments that have proven effective with parents of children with other types of medical problems, for example, parents of children with cancer. It is the hope of the investigators that this intervention will effectively reduce symptoms of anxiety of NICU parents as well as the likelihood of developing subsequent psychological disorders.
Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis. Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age. The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. \[an 8-point difference is considered a clinically meaningful difference\] Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay. The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age. Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being. The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).
This is a randomized controlled study of parents of children to be discharged from the neonatal intensive care unit at Bellevue and Elmhurst hospitals. A total of 425 subjects will be recruited across two sites over preparatory phases and two primary study phases.
This is a non-randomized, un-blinded feasibility study project comparing the Length of Stay (LOS) of Neonatal Intensive Care Unit (NICU) infants diagnosed with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent.
This study is about reducing the risks of smoke-related infant health problems. Research has shown that infants exposed to secondary smoke have higher risks of delayed lung development, respiratory illnesses, wheeze, cough, asthma, middle ear disease, and sudden infant death syndrome. Infants who have experienced low birth weight or required mechanical ventilation may be at an even greater risk for the negative effects of smoking. The purpose of this study is to evaluate the effectiveness of a 3-session program aimed at assisting the primary care giver in reducing risks to their child's health by decreasing infant smoke exposure in their home and/or reducing overall cigarette use. Caregivers will not be required to quit smoking to take part in this program. This information will, in the future, help to identify and improve ways of reducing health problems and perhaps death in children.
This study will explore the RAM Nasal Cannula as a means of providing CPAP and Bi-PAP to infants 28-42 weeks gestation to prevent nasal septal erosion.
The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the Neonatal Intensive Care Unit (NICU). The FCC intervention will consist of communicating an expectation that all NICU parents be present at minimum 4 hours/day versus the current practice of telling families to "come as much as they can" that has resulted in inconsistent parent presence.
To learn if and how the physical and occupational therapy program in the Newborn Critical Care Center helps parents with their stress levels and ability to meet the needs of their preterm infants.
The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU). By moving beyond the basic infant care tasks taught by parenting programs and instead comprehensively training parents to use evidence-based family management skills, we hypothesize that our intervention, called PREEMIE PROGRESS, will better equip parents to meet the chronic, complex healthcare needs of their preterm infant.
The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination
Dino EGG mother's voice exposure and multisensory processing in Neonatal Intensive Care Unit infants. This is a 2 phase prospective comparative effectiveness trial of our parents' voice intervention with 290 hospitalized preterm infants. As a part of a previous project, an early technology development award from the Nationwide Children's Hospital (NCH) Technology Office allowed us to develop 10 functioning prototypes of the DINO EGG speakers, a NICU-safe and developmentally appropriate music player that delivers parent's voice to the bedside of NICU infants. The device passed NCH NICU-safe products committee and has been used in the clinical setting delivering clinical music therapy services (available at bedside to play parents' voice). The first phase of the current study is to test an updated prototype version of the device that replicates a previously FDA (and NCH NICU-safe products) proved device called Pacifier Activated Lullaby (PAL), used and described in IRB15-01035, but being discontinued by the company. The discontinuation is not due to safety or health benefits concerns. Therefore, no device available on the market currently exists to accomplish NICU parents' voice delivery in a consistent and safe manner, the investigators modified a 510K-approved feeding device that is no longer available and whose intellectual property rights have expired. The device's air displacement sensor, which fits into a standard NICU pacifier, allowed the investigators to deliver processed and developmentally appropriate recordings of parent's voice, contingent upon the infant producing effort to receive it. Intellectual property rights were filed for the modifications and use process through the technology transfer and legal office at NCH. Therefore, phase I will test the usability of the device (safety for the NICU was confirmed), not the effectiveness of the parents' voice delivery for the infant. Parent and nursing questionnaires about the importance of the device availability and its usability will be collected from parents and Registered Nurse (RN) staff that choose to provide the feedback.
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations. This MR system has a smaller size and design features that may make it more feasible to locate the system in close proximity to care areas for neonates (birth - 1 month) and infants (less than 1 month to two years), such as clinical neonatal intensive care units (NICUs) and other infant and neonatal care departments.
Preterm infants face many feeding challenges during hospitalization which can prolong hospitalization, raise parental anxiety and can lead to medical instability. The Feeding Progression study will randomize preterm infants to one of two currently accepted oral feeding schedules; oral feed attempts every 3 hours or every 6 hours. The study will collect data on oral feeding success, milk transfer, sucking strength, growth and medical complications.
Babies born too soon, premature babies, can have complications following birth because their systems are immature. Hospitals help prevent deformities and delays in motor development by using therapeutic positioning to provide containment as they would experience in the womb. They also often have trouble eating. They have discomfort, are irritable, refuse to eat and cry because their digestive system is immature. The neonatal intensive unit can create stress and disrupt their sleep. Going from active to deep sleep is essential for infant brain development, learning and memory formation. Their sleep states early in life predict their developmental outcome. The purpose is to determine whether a conformational positioning system, one that can mold to the baby and contain him or her, will allow more time asleep in premature infants with feeding problems compared to the standard crib mattress. We hypothesize that the number of total sleep time will be longer and the number of arousals out of sleep lower when they are sleeping on the conformational positioning system compared to the mattress.
A randomized, controlled, parallel group design will be used to test whether a Secondhand Smoke Exposure program initiated in the hospital and completed in the home using motivational interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC) with Neonatal Incentives Care Unit Infants' parents.
The specific aim of this pre-post trial is to compare data regarding oral feeding, length of stay, and growth outcomes of 100 NICU infants to these same outcomes following the implementation of a developmentally supportive, infant driven feeding program with the NICU staff, specifically the Supporting Oral Feeding in Fragile Infants (SOFFI) infant feeding program on a second sample of 100 NICU infants at Children's Memorial Hospital. The specific research questions considered in this study are: 1. What is the impact of implementing the SOFFI on the oral feeding outcomes of medically fragile infants in the NICU at discharge and at 3 months post-term? 2. What is the impact of implementing the SOFFI on the growth outcomes of medically fragile infants in the NICU at discharge and at 3 months post-term? 3. What is the impact of implementing the SOFFI on the length of stay of medically fragile infants in the NICU? 4. What is the impact of implementing the SOFFI on the clarity and consistency of NICU staff evaluations and communications related to managing oral feedings with medically fragile infants?
Human milk feeding is associated with great benefits to the health and development of infants, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant. The use of donor human milk products for very low birth weight infants as an alternative to cow milk has risen dramatically in the past year. Purpose: To evaluate post-discharge growth and neurodevelopment of infants less than or equal to 1250 grams birth weight receiving an exclusive human milk protein diet.
The purpose of this study is to test the efficacy of a family nurture intervention in the neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family nurture are compared to infants receiving standard NICU care. The intervention enhances mother/infant interactions that are vital to early development in the infant. The main goal is to get the mother and infant into biological synchrony, emotional attunement and mutual calm through an activity referred to as a "calming cycle". Mother's are encouraged to engage in the calming cycle activities as much as possible. Her increased effectiveness in calming her infant is hypothesized to improve the mother's view of her baby, reduce negative emotions about having delivered a baby prematurely, and help her gain confidence in her care-taking abilities, which in other studies predicted shorter length of stay and fewer re-hospitalizations. Another goal is to assist mothers in repeating the calming cycle activities providing appropriate types of stimulation for their babies that are important for social, emotional, and neurobehavioral development. Since preterm babies are often easily upset, mothers will be taught how to comfort and calm their babies. Assessments in the NICU and in follow-up visits for two years will test the immediate and long-term effects of this new approach to the nurture of prematurely born infants.
Infants born prematurely or with complex congenital abnormalities are surviving to discharge in growing numbers and often require significant monitoring and coordination of care in the ambulatory setting. The specific aims of this project are to determine the effectiveness of a redesigned discharge process that includes a Health Coach and an expanded discharge binder to improve health outcomes in the post discharge follow-up period as compared with usual care. The outcomes to be evaluated include the occurrence of adverse events in the post-discharge period, quality of follow up care, and caregiver satisfaction with the process.
Infants will be observed in the neonatal intensive care unit for 4 hours. The observer will note the timing of oxygen saturation alarms, staff response, and interrupted staff activities.
The purpose of this study is to see if daily massage therapy will help premature infants respond to stress better, as well as improve their growth and neurobehavioral development.
The purpose of this study is to determine whether implementing the Newborn Individualized Developmental Care and Assessment Program increases NICU nurses' sensitivity in meeting the developmental care needs of preterm infants.
The purpose of this study is to evaluate the impact of the NIDCAP program of individualized patient consultation on the neurobehavioral organization of transported preterm infants in the NICU. Behavioral response to routine caregiving will be compared between infants in the pre-NIDCAP group to infants in the post-NIDCAP group. And it is this behavioral response that will be used to evaluate the effectiveness of the NIDCAP program.
This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral therapy (CBT) sessions.
BACKGROUND: Annually \>400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be classified as children with special health care needs (CSHCN) who will require health and related services of a type or amount beyond that required by children generally. NICU parents report increased anxiety and stress during their stay and transition home from the NICU. Short-term peer-to -peer programs during hospitalization decrease stress, anxiety and depression for mothers, however, no studies have evaluated the effects of long term post-discharge peer support. Children's National (CN) provides medical home services to CSHCN through its Parent Navigator Program (PNP). Parent Navigators (PNs) are CSHCN parents who provide peer emotional support, access to community resources, and assistance with navigating complicated health systems. NICU graduates and their caregivers may benefit from support provided by PNs after discharge. No data regarding the impact of PNs on patient and family outcomes of the NICU graduate are available. OBJECTIVE: To assess the impact of a PNP on a parent's self-efficacy, stress, anxiety, depression; infant health care utilization, and immunization status. METHODS: 300 NICU graduates will be randomized to receive either PN for 12 months (intervention group) or usual care (comparison group). Baseline data at 1 week, 1, 3, 6, and 12 months after discharge will be collected from caregivers in both groups including scales for self-efficacy, stress, anxiety, and depression, infant healthcare utilization and immunization status. Outcomes will be compared at 12 months. PATIENT OUTCOMES (PROJECTED) The study outcomes are parental self-efficacy, stress, anxiety, and depression; infant health care utilization and immunization status. ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in the NICU can reduce anxiety and depression in caregivers. It is unclear whether peer support after discharge, when a family is faced with the total care of their child without structured supports, can significantly impact parents' ability to care for their child. The investigators anticipate that this simple intervention will increase self-efficacy in caregivers, reduce stress, anxiety, and depression, in turn resulting in improved health outcomes for their child.
Up to a quarter of the families with preterm infants have unmet social needs, such as housing or job insecurity, which represent adverse social determinants of health (SDOH). Preterm infants are especially vulnerable to the social conditions they grow up in, with sustained impacts on function across multiple organ systems. The goal of this study is to translate an established model of SDOH screening and referral from the outpatient setting to the NICU, thereby maximizing the potential to offset the effects of adverse SDOH on vulnerable mother-preterm infant dyads.