Clinical Research Directory

Prophylactic DR-CPAP on Late Preterm Infants Born by C-section: an RCT

A Pragmatic Randomized Controlled Pilot Trial to Evaluate the Impact of Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen in Spontaneously Breathing Late Preterm Newborn Infants Born by Cesarean Delivery, Compared to No Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen, on the Need for Further Respiratory Support Leading to NICU Admissions.

Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are: Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique? Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant. Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will: Receive surfactant replacement therapy by the less invasive surfactant administration technique. Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.

Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care

The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the same effects as when administered at in-person facilities.

Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight

The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants. Advances in neonatal care have significantly improved survival rates of infants born with a gestational age of less than 32 weeks and/or a birth weight below 1500 g. However, these infants remain at high risk for multiple complications affecting neurological, pulmonary, cardiovascular, renal, and other organ systems, which may lead to long-term morbidity and reduced quality of life. Identifying early risk and protective factors is therefore essential to improve outcomes and develop targeted interventions. The primary objective of the project is the prospective and structured collection of clinical data as well as biological samples within a standardized interdisciplinary follow-up program for preterm infants. The study aims to identify biological, clinical, and environmental factors associated with the development and long-term outcomes of different organ systems. The study population includes infants born with a gestational age of less than 32 weeks and/or a birth weight below 1500 g who receive care at the perinatal center of the University Hospital Cologne. Participation requires informed consent from the parents or legal guardians. There are no specific exclusion criteria. Participants will be followed within the established preterm follow-up program over several years, allowing longitudinal assessment of clinical outcomes and developmental trajectories. Primary outcome is survival without impairment (e.g. neurocognitive, pulmonal, cardiovascular, renal) at the age of 5 years. Secondary outcomes include duration of breastfeeding, nutritional status, body mass index, and parental stress and bonding. In addition, biological samples will be collected to enable the creation of epigenetic, gene expression, and cytokine profiles. These data will contribute to the identification of predictive biomarkers that may help stratify risk and guide individualized preventive or therapeutic strategies in preterm infants. By combining comprehensive clinical data with biological samples in a dedicated data and biobank, the Neo-Life project aims to generate a valuable resource for translational research. The findings are expected to improve understanding of the mechanisms underlying organ development and long-term health in preterm infants and to support the development of early interventions that may prevent or mitigate adverse outcomes.

PPROM Registry (Preterm Premature Rupture of Membranes)

Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible for 40% of preterm births in the United States. The PPROM Registry aims to identify possible causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care, and to review short term and long term outcomes of affected pregnancies and births.

Infant Massage for Lymphedema and Comfort in Preterm Newborns

This randomized controlled trial investigates the effectiveness of infant massage in reducing symptoms of immobilization-related lymphedema and improving comfort in preterm newborns hospitalized in the Neonatal Intensive Care Unit (NICU). Preterm infants frequently develop lymphedema due to their immature circulatory systems and prolonged lack of movement. The study compares two groups of infants: one receiving standard care and another receiving a daily 15-minute massage therapy session for 14 consecutive days in addition to standard care. Researchers will evaluate the impact of the massage by measuring the circumference of the infants' wrists, elbows, ankles, and knees to assess fluid reduction. Additionally, the infants' comfort levels will be assessed using the Premature Infant Comfort Scale (PICS). The goal is to determine if massage can serve as a safe, non-invasive method to manage lymphedema and reduce distress in this vulnerable population.

Biomarkers Study in Infants With Prior Neonatal Brain Injury

This research focuses on the long-term cognitive development of children, including healthy infants and those who had a perinatal brain injury. As part of this research study, children complete in-person games and assessments at UW-Madison University Hospital. Children will also take part in an EEG assessment. Parents will be asked to fill out questionnaires about their child's behavior and stress in the home.

taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort, and during daily treatment paired with breastfeeding the infant will continue to receive this level of electrical stimulation, coinciding with latching and sucking, repeated over the duration of the feed. Investigators will collect information about the pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow techniques by the infant from parents and the lactation consultant. Investigators will also evaluate parental satisfaction associated with their infant's ability to breastfeed after taVNS by providing parental satisfaction surveys at the beginning, after 1 and 2 weeks, and at 3 months after the end of the study to assess infants' progress in and maintenance of breastfeeding abilities. If the pairing of breastfeeding with taVNS is able to result in improved outcomes of effective breastfeeding in infants in the neonatal intensive care units, this intervention could be further utilized by NICUs to increase the rate of premature and sick term infants who are successfully able to breastfeed at the time of discharge and maintain breast feeding longer after discharge. This would allow premature infants to acquire the many benefits of breastmilk as well as contribute towards the strengthening of the maternal-infant bond that breastfeeding has been shown to enhance.

Parent Training for Parents of Toddlers Born Very Premature:

The purpose of the study is to test the effects of the ezParent (web-based parent training program) intervention and telephone coaching calls (coach) on parent and child outcomes after 3-, 6-, and 12-months. Parents (n=220) will be randomized using a 2 x 2 factorial design to: (1) ezParent+coach, (2) ezParent, (3) Active Control+coach, or (4) Active control. The investigators will address these aims: 1. Determine the independent and combined effects of ezParent and coaching calls on parent outcomes. H1: The ezParent and ezParent+coach groups will report greater improvements in parenting skills and self-efficacy and reductions in harsh and negative discipline; and exhibit observed improvements in parent-child emotional connection vs. active control H2: There will be a synergistic effect of ezParent and coaching calls on parent outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls. 2. Determine the independent and combined effects of ezParent and coaching calls on child outcomes. H3: The ezParent and ezParent+coach groups will report greater reductions in child behavior problems vs. active control. H4: There will be a synergistic effect of ezParent and coaching calls on child outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls. 3. Determine differences in ezParent engagement with and without coaching calls. Engagement will be assessed by frequency (the number of times parents use the program), activity (proportion of material completed), and duration (amount of time parents use the program). H5: Relative to the ezParent only group, the ezParent+coach group will exhibit higher engagement with the ezParent.

Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy

Mueller polarimetric colposcopy appears to be a powerful tool for evaluating cervical microstructure modification during pregnancy. Some polarimetric parameters of the uterine cervix can be correlated with the gestational age. The uterine cervix's polarimetric analysis could make it possible to accurately predict the term of childbirth and be used as a screening tool for preterm birth.

Impact of Moderate Preterm Birth on Vocabulary Acquisition

Children born prematurely may present a neurodevelopmental disorder with a language delay diagnosed as early as 2-3 years of age. This situation is not uncommon: each year in France, approximately 35,000 children are born between 32 and 36 weeks of amenorrhea. In our most recent work, we have shown that moderate premature infants show an attenuated cortical response to a vowel change, suggesting a deficit in the cortical encoding of vowels. This work needs to be continued in order to better understand syllable encoding and identify the neuroplasticity mechanisms underlying early speech encoding. The identification of markers to predict language development is essential for the screening of these children at risk of language delay. These children could thus benefit from early adapted care even before the appearance of language deficits.

Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)

Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome. The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity. The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.

The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body Weight

This is a randomized controlled experimental study evaluating the effects of oral motor intervention and chronobiological approach to feeding model applied to preterm infants on feeding readiness, transition to total oral feeding and body weight.

Azithromycin and Ampicillin for Late PPROM

The goal of this clinical trial is to learn whether adding azithromycin to the standard antibiotic treatment (ampicillin) improves newborn outcomes in women with preterm premature rupture of membranes (PPROM) between 34.0 and 36.6 weeks of pregnancy. The main question it aims to answer is: Does the combination of ampicillin and azithromycin lower the risk of serious neonatal health problems compared to ampicillin alone? Researchers will compare two antibiotic regimens: Ampicillin alone, which is the current standard care Ampicillin with azithromycin, a broader regimen that may better prevent infections and prolong pregnancy Participants will: Receive one of the two antibiotic treatments during hospitalization. Be monitored until delivery for signs of infection and labor All participants will stay in the hospital until delivery. The study also looks at how the antibiotic choice may affect the time between membrane rupture and delivery, maternal infections, and the need for neonatal intensive care.

Optimizing Family Counseling for Anticipated Extremely Preterm Delivery

Antenatal family counseling for anticipated extremely preterm deliveries remains ethically and practically challenging for maternal-fetal medicine specialists and neonatologists alike. The overall goal of this project is to improve antenatal counseling and counseling outcomes for families facing anticipated extremely preterm delivery through innovative, interdisciplinary simulation-based education for maternal fetal medicine specialists and neonatologists, using language preferred by families, and focusing on eliciting values and building partnerships through advanced communication and relational skills.

Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset

The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

Air Pollution and Pregnancy

We are an inter-disciplinary team of UK scientists with expertise in obstetrics, women's and child health, epidemiology, climate science, inflammation, computational modelling, machine learning and artificial intelligence. Together we have a long history with existing strengths underlying preterm birth research that crosses multiple disciplines and an excellent track record of publications and awards leading research in preterm birth. We aim to develop and validate a deep learning model to predict the risk of preterm birth and other adverse pregnancy outcomes using data from EPIC electronic health records at University College London Hospital Trust (UCLH) for a cohort of 18000 patients. We will obtain corresponding data on exposure to ambient pollution using non-identifiers for postcode (area) and date of delivery (month). The model will review the temporal sequence of events within a patient's medical history and current pregnancy, identifying significant interactions and will predict the risk of preterm birth. It will also determine the threshold and gestation at which pollution exposure has the greatest impact.

Evaluation of the Health Effects of the Air Purifier in Preterm Infants After Discharge

Participant's baby was born prematurely and had underdeveloped lungs at birth. Most premature infants require mechanical ventilation after birth, which increases the risk of lung injury and may lead to varying degrees of bronchopulmonary dysplasia (BPD). Investigators believe that introducing an air purifier into your home environment after Participant's baby is discharged could help improve their lung development. This study aims to non-invasively measure baby's transcutaneous carbon dioxide (PtcCO₂) levels and blood oxygen saturation (SpO₂) at home, both with and without the use of an air purifier. In addition, investigators will collect data from Kaohsiung Medical University Hospital medical records regarding the number of visits, respiratory status, height, weight, head circumference, and developmental progress. Health questionnaires will also be administered to assess changes in health outcomes and provide recommendations on improving indoor air quality in Participant's home.

Postpartum Care in the NICU (PeliCaN) Transitions

This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.

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.

Non-invasive Ventilation in Preterm Infants

This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional. For all participants prospective data collection will be conducted by chart review and by downloading ventilatory data from the ventilator. A registration of respiratory severity score will be done by a caregiver during the weaning period. This consists of a visual assessment of the work of breathing every 2 hours. For participants on NIV-NAVA consenting to the interventional part of the study a titration procedure will be conducted, afterwards serial electrical impedance tomography and lung and diaphragm ultrasound measurements will be done.

Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants

The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants. The device is designed to be used at an age equivalent to 32 weeks of gestation or older and to integrate readily into clinical practice for use by nurses and therapists staffing Level II to Level IV NICUs. Preterm born infants are at high risk for neurosensory impairments and developmental delays. In the NICU, infants are often deprived of infant-directed parental speech because of numerous challenges to parental visitation, resulting in reduced differentiation of speech sounds, altered brain structure and poor language outcomes. The study will explore the effectiveness of a novel medical device designed for infant learning through contingent sucking on a pacifier equipped with a sensor for suck pressure/timing, connected to a speaker that delivers mother's voice. The study will test the hypothesis that there will be a greater response difference between speech sounds on EEG, for infants receiving the suck-contingent mother's voice intervention than for infants hearing the same amount of non-contingent mother's voice from a speaker device.

EEG and NIRS in Preterm Infants

Experimental cross-sectional study of a single application (vojta therapy or massage) in preterm and non-preterm infants to test whether there are differences in brain activation and oxygenation that occur with both techniques between term and preterm infants. Secondly, the brain activation and oxygenation produced by both physiotherapy techniques will be tested separately to establish comparisons between the two groups. Finally, between 3 - 6 months, we will analyse whether there are changes in gaze fixation (eye tracker) in the 4 study arms to see if there are differences between term and preterm infants but also the differences between the immediate effectiveness of both techniques.

Spinal Stimulation and Mobility Devices

This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of these innovative techniques on mobility in children with cerebral palsy.