Clinical Research Directory

The Periviable GOALS Decision Support Tool

The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0/7 - 25 6/7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.

Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk

The goal of this pilot randomized controlled trial is to learn whether a family-centered early intervention program, delivered remotely to parents and carried out at home, can support the development of infants who were treated in a neonatal intensive care unit (NICU) and are at mild-to-moderate developmental risk (for example, due to preterm birth or low birth weight). The study will also look at whether the program helps parents' stress and well-being. The main questions it aims to answer are: Does the remote family-centered early intervention program improve infants' motor, cognitive, language, and neurological development compared with standard care? Does the program reduce parental stress and anxiety and improve parents' perception of family-centered care? Researchers will compare an intervention group with a control group receiving standard information and routine follow-up, to see whether the program leads to better infant and parent outcomes. The study will include 36 infants (18 per group) with a corrected age of 6 to 10 months. Participants in the intervention group will: Attend weekly online sessions with the research team for 10 weeks Carry out a home-based developmental activity program with their infant Share short videos of home practice and receive feedback, with follow-up via messaging Participants in the control group will receive standard information and routine follow-up. Infant development will be assessed with the Bayley-III and SINDA, and parents will complete questionnaires on stress, anxiety, and family-centered care. Assessors will be blinded to group assignment.

Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes

The purpose of this study is to evaluate the feasibility, acceptability, and preliminary effects of the Parent-Facilitated Early Oral-Sensory Experience (PEOE) program for very preterm infants in the Neonatal Intensive Care Unit (NICU). Very preterm infants (born before 32 weeks gestational age) often face challenges developing oral feeding skills. The PEOE intervention involves training parents to deliver gentle, synchronized oral-sensory stimulation-such as placing small droplets of human milk in the infant's mouth paired with gentle touch, voice, and scent-starting immediately before gavage feedings and potentially continuing into the feeding. This study uses a sequential two-group design. The first group of parents and infants will receive usual NICU care. The second group will receive the PEOE intervention. Researchers will measure how feasible and acceptable the program is for parents and staff, infant physiological responses, feeding skill development, length of hospital stay, and parental emotional well-being.

Post-Care Positioning and Comfort in Late Preterm Infants

This study examined the comfort of late preterm infants (born at 34 0/7 to 36 6/7 weeks of gestation) placed in four positions after routine nursing care in a neonatal intensive care unit. After each of four night-time care episodes, every infant was placed sequentially in the supine, left lateral, right lateral and prone positions within a nest for 15 minutes each, and comfort was assessed with the Premature Infant Comfort Scale at the 1st, 5th and 15th minutes.

nCPAP Versus High-Flow Nasal Cannula in Preterm Infants With RDS

This randomized controlled trial aims to compare the efficacy and safety of nasal continuous positive airway pressure versus high-flow nasal cannula as initial non-invasive respiratory support in preterm infants with respiratory distress syndrome.

Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates

Pulse oximeter probes are used to continuously monitor oxygen levels in newborn babies in intensive care. These probes are usually attached to the baby's hand or foot with adhesive tape and must be moved to a new site every few hours. Repeatedly sticking and removing adhesive can damage the delicate skin of premature babies. The investigators have developed a new way to secure the probe without any adhesive touching the skin: the probe's adhesive side is attached to a soft, self-adhering (cohesive) bandage that wraps around the baby's hand or foot. The bandage sticks only to itself, not to the skin. The purpose of this study is to find out whether securing the probe with a cohesive bandage protects the skin better than the standard method of taping the probe directly to the skin. Sixty-four premature babies (born at 32 to 36 weeks) will be randomly placed in one of two groups. In both groups, the probe will be placed on each hand and foot for four hours in turn, for a total of 16 hours. The skin under the probe will be photographed and scored by two nurses who do not know which method was used.

Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes

Objective: This study aims to investigate the association between maternal serum placental growth factor (PLGF) and nucleosome levels in early pregnancy and adverse pregnancy outcomes, and to evaluate their predictive value for the occurrence of preeclampsia, fetal growth restriction, preterm birth, and other pregnancy complications. Method: This observational prospective cohort study enrolls pregnant women who undergo non-invasive prenatal testing (NIPT) at 12-14 weeks of gestation and deliver at the Second Affiliated Hospital of Wenzhou Medical University between June 2026 and July 2027. Maternal peripheral blood samples are collected for NIPT analysis, and plasma nucleosome concentrations and PLGF levels are measured. Participants are categorized into four groups based on the 95th percentile (P95) of nucleosome and PLGF levels established from a healthy pregnant population at the same center during the same period: (1) both normal, (2) elevated nucleosome only, (3) elevated PLGF only, and (4) both elevated. Maternal demographic characteristics, laboratory indicators, and pregnancy outcomes are collected and compared across groups. The incidence of adverse pregnancy outcomes, including preeclampsia, fetal growth restriction, preterm birth, recurrent miscarriage, and neonatal complications, is recorded. The relationship between nucleosome and PLGF levels and adverse pregnancy outcomes is analyzed to explore their potential as early predictive biomarkers for placental dysfunction-related complications.

Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates

The goal of this clinical trial is to learn if nasal high frequency oscillatory ventilation (nHFOV) works no worse than nasal intermittent mandatory ventilation (NIMV) as early breathing support. The study will include preterm babies born from 28 weeks through 36 weeks of gestation..All babies will have respiratory distress syndrome and need noninvasive breathing support within six hours of birth. Noninvasive support helps breathing through a nasal interface without placing a tube in the windpipe. The main questions it aims to answer are: Does nHFOV work no worse than NIMV in preventing the need for a breathing tube within 72 hours? What medical problems occur in babies receiving each type of breathing support? Researchers will compare nHFOV with NIMV. nHFOV uses rapid, small pressure waves. NIMV provides regular supported breaths. Both methods are routinely used at the study hospital. Babies will: Be assigned by chance to receive either nHFOV or NIMV Receive regular monitoring of breathing, oxygen levels, and medical condition Be assessed for the need for a breathing tube during the first 72 hours Be followed for complications of disease and assigned treatment during hospitalization and after discharge when required The study will also record breathing support duration, hospital stay, survival, chronic lung disease, severe bleeding in the brain, and eye disease related to prematurity. The findings may help doctors choose breathing support for preterm babies with respiratory distress syndrome.

Spinal Stimulation and Mobility Devices

This research study will combine non-invasive spinal stimulation with an ankle exoskeleton to examine the acute impact of the stimulation on gait in children with cerebral palsy.

PREterm Infants With Bronchial Obstruction - Prospective Study of Efficacy and Safety of Inhaled Tiotropium

The purpose of this clinical trial is to evaluate the efficacy and safety of inhaled tiotropium bromide (Spiriva Respimat) in preterm-born children and adolescents suffering from chronic bronchial obstruction. Preterm infants often experience persistent narrowing of the airways, which leads to shortness of breath, chronic respiratory symptoms, and reduced exercise tolerance. Tiotropium is a long-acting muscarinic antagonist (LAMA) that helps dilate the airways and facilitate breathing. While this medication is already approved for pediatric patients aged 6 years and older with severe asthma, its efficacy and safety have not yet been validated in the specific population of preterm infants with bronchial obstruction. This study aims to fill this clinical knowledge gap. This is a non-commercial, monocentric, prospective, randomized, open-label, phase IV study utilizing a 2x2 crossover design. The trial will enroll 50 participants aged 6 to 18 years. Each participant will undergo two distinct 3-month phases: a treatment period with daily inhaled tiotropium (5 µg once daily) and a control observation period without long-term anticholinergic therapy. The sequence of these periods will be randomly assigned to each participant. The primary objective is to demonstrate lung function improvement by evaluating the change in forced expiratory volume in 1 second (FEV1) expressed in liters and Forced Vital Capacity (FVC) expressed in liters between the treatment and control periods. No blood samples or invasive procedures are required for this study.

Predictors of Prolonged Mechanical Ventilation in Preterm Infants

This prospective cohort study aims to identify the independent predictors of prolonged mechanical ventilation in preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children Hospital.

Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age

Despite improved survival of extremely premature infants in recent decades, neonatal intensive care unit (NICU) graduates are diagnosed with asthma, sleep disordered breathing (SDB) in childhood, and neurodevelopmental impairments (NDI) at significant rates, disproportionate to their term peers. Early detection and intervention are critical to mitigate the impact of these impairments. Mechanisms leading from premature birth to these undesirable outcomes remain unclear, and accurate prognostic measures are lacking. This study wants to learn if these problems are related to certain patterns of breathing that babies had while they were in the NICU.

Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study

This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 674 Medi-Cal eligible pregnant individuals in Fresno, California. The goal is to see whether group prenatal care with wrap around services versus individual prenatal care supplemented by services covered by the California Department of Public Health Comprehensive Perinatal Services Program (CPSP) results in less depression and anxiety, and more respectful, more person-centered maternity care and lower rates of preterm birth.

Predictors of Postnatal Growth Failure in Preterm Infants

This prospective observational study aims to identify the clinical and nutritional predictors of postnatal growth failure among preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.

Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants

Compare the bacterial digestive microbiota during the stay in neonatal intensive care between a group of premature newborns developing a NEC (necrotizing enterocolitis) and a group of newborns free from NEC.

Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants

Babies born very prematurely are at risk of intraventricular hemorrhage (IVH), which is bleeding in or around the fluid-filled spaces of the brain. Most IVH occurs during the first week after birth. Human colostrum and early breast milk contain growth factors, neurotrophic factors, immune-modulating substances, antioxidants, and other biologically active components that may have neuroprotective effects. This study will evaluate whether giving very small amounts of a baby's own mother's fresh breast milk as nasal drops during the first 7 days of life may help prevent IVH in infants born at 29 weeks' gestation or earlier. Approximately 67 eligible infants will be enrolled prospectively at Women's Hospital and St. Boniface Hospital in Winnipeg, Manitoba, Canada. At each scheduled study care session, fresh mother's own milk will be administered intranasally at 0.2 mL per nostril (0.4 mL total) before routine nursing care and, if tolerated and the infant remains clinically stable, repeated after care. Thus, a completed care session provides up to 0.8 mL. Study administration will be coordinated with 2-4 routine care sessions per day for 7 consecutive days, corresponding to a planned total daily volume of 1.6-3.2 mL. The main study outcome is whether IVH of any grade is present on the routine cranial ultrasound performed at 4 to 7 days of life. Other outcomes include severe IVH, progression of IVH, post-hemorrhagic ventricular complications, mortality before hospital discharge, and the safety and tolerability of intranasal mother's own milk. Outcomes in the prospectively treated infants will be compared with those of eligible infants previously cared for at the same neonatal intensive care units between 2020 and 2025. Statistical methods using propensity score weighting will be used to account for measured differences between the prospectively treated infants and the historical comparison group.

Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants

Infants who are born prematurely have immature nervous and cardiorespiratory systems. These are systems infants use to breathe, to move oxygen throughout their bodies, and to maintain safe and stable levels of oxygen and carbon dioxide. The goal of this study is to better understand how these immature systems affect long term development, such as brain, heart, and motor function (movement) with several innovative, integrated physiological measures. We hope this will allow us to begin to find better ways to help premature infants breathe and to optimize their development.

Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

This is a pilot project designed to test the feasibility of implementing a community health worker (CHW)-led intervention to improve nutritious food access and consumption among pregnant people and to evaluate the effectiveness of this approach. The project will be conducted in partnership with the Greater Cleveland Food Bank and the Better Health Partnership Community Health Worker HUB

Growing Little PEAPODS Study

The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth and development. Participants will: * have body growth measurements collected using the PEAPOD device * have nutritional information collected, and * be followed for neurodevelopmental outcomes Participants can expect to be in the study for 36 months.

Higher-Dose Dexamethasone Improves Breathing and Shortens NICU Stay in Preterm Babies

The goal of this observational study was to compare two doses of dexamethasone given to pregnant women at risk of preterm birth. Dexamethasone is a medicine used before birth to help a baby's lungs mature. This study looked at preterm babies born between 26 and 36 weeks of pregnancy. Researchers compared babies whose mothers received dexamethasone 12 mg every 12 hours for 48 hours with babies whose mothers received dexamethasone 6 mg every 12 hours for 48 hours. The main questions this study aimed to answer were: * Did the higher dose of dexamethasone help preterm babies need breathing support for a shorter time? * Did the higher dose help shorten the babies' stay in the Neonatal Intensive Care Unit (NICU)? * Was the higher dose as safe as the lower dose for babies and mothers? Researchers reviewed medical records from Stella Maris Women's and Children's Hospital from January 2018 to January 2023. They looked at neonatal outcomes, including breathing support, respiratory distress syndrome, length of NICU stay, low blood sugar in babies, infection in mothers, and developmental problems at 24 months.

Low Dose Aspirin vs Placebo in Prevention of Recurrent Spontaneous Preterm Labour

Preterm birth-defined as delivery before 37 weeks of gestation-is a leading cause of neonatal morbidity and mortality worldwide, particularly in resource-limited settings. Women with a history of spontaneous preterm birth face a significantly higher risk of experiencing premature labor in subsequent pregnancies. Impaired uteroplacental blood flow, inflammation, and abnormal clot formation are key contributing factors to spontaneous preterm delivery. Low-dose aspirin is an affordable, widely available medication that exerts anti-inflammatory and antithrombotic effects by inhibiting platelet aggregation and prostaglandin synthesis. This study aims to evaluate whether low-dose aspirin (75 mg daily), initiated between 8 and 16 weeks of gestation, can effectively reduce the incidence of recurrent spontaneous preterm labor in pregnant women with a prior history of premature delivery compared to a placebo. Participants will be monitored throughout their pregnancy up to 36 weeks or delivery to evaluate gestational age at birth and labor outcomes.

Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit

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).

Wireless MicroPremVitals Button Sensor in the NICU

A wireless and miniaturized vital sign (ECG, SpO2, Skin Temperature) sensor system, MicroPremVitals Button Sensors was developed by the Dr. John Rogers Laboratory (QSIB- Northwestern University, Chicago, USA) to facilitate vital sign monitoring in extremely preterm neonates.

Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospital Discharge

This pilot study evaluates the feasibility, usability, and clinical utility of the Woddle Smart Changing Pad and companion mobile application for infant monitoring following hospital or NICU discharge. The study also compares infant weight measurements obtained using the Woddle scale with those from standard clinical reference scales to assess accuracy and reliability.