Clinical Research Directory

Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns

This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care. Parents of high-risk newborns admitted to a neonatal intermediate care unit will be enrolled. Families in the control group will receive routine nursing education provided during hospitalization. Families in the intervention group will receive a structured nursing guidance program that includes step-by-step parent education, written educational materials, instructional videos, and active father participation in breastfeeding support and infant care. The study will compare the two groups on maternal breastfeeding self-efficacy, perceived spousal support, perceived nursing support, parental stress, breastfeeding-related anxiety, and breastfeeding practices at hospital discharge and one month after discharge. The findings may help develop family-centered nursing interventions that enhance paternal involvement and improve breastfeeding outcomes for families with high-risk newborns.

Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)

Early vascular aging has its origins in fetal and neonatal life. The NEOVASC clinical trial aims to determine the effects of an exclusive human milk diet in extremely preterm infants on long-term cardiovascular health.

Maternal Stress, Milk Composition, and Preterm Neurodevelopment

This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.

Automated Apnoea Detection in Preterms on Non-invasive Ventilation

The aim of this study is to monitor the frequency of apnoeas (pauses in breathing) on various methods of non-invasive respiratory support that are detected by an automated machine-learning (ML) model based on diaphragmatic electromyography (dEMG), in infants born at less than 32 weeks of gestation. Our hypothesis is that the ML algorithm will improve identification of apnoeic episodes and their classification to central or obstructive. The study will measure outcomes including the number of apnoeic episodes during the monitoring period, their classification to central and obstructive apnoeas and the predictive ability of the machine-learning algorithm to correctly identify and classify these episodes compared to those documented in nursing charts. Correct classification of apnoeic episodes may help identify underlying causes that require specific intervention.

Prevention of Developmental Delay and Xylitol (PDDaX) Study

The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as compared to the gold-standard yet more cumbersome and costly Kaufman Assessment Battery for Children-II (KABC-II) among (1) n=500 formerly preterm children and (2) n=500 formerly term children. Additionally, we will evaluate the effects of gestational xylitol exposure compared to a lack of gestational xylitol exposure on neurodevelopmental outcomes of children aged 4-8 years old in Malawi through the following four neurodevelopmental tests: (3) KABC-II (cognitive outcomes), (4) EF Touch (executive functions), (5) Strengths and Difficulties Questionnaire (social-emotional outcomes), and (6) MDAT (motor and cognitive outcomes). The researchers will leverage subjects who completed the parent Prevention of Prematurity and Xylitol Trial, which enrolled 10069 pregnant individuals in Malawi and demonstrated a significant 24% reduction in incidence of preterm birth and low birthweight offspring in gravidae who chewed xylitol-containing chewing gum compared to those who did not. By ensuring that these offspring did not have higher rates of neurodevelopmental impairment, the study will promote promising multi-center international and domestic trial evaluating the impact of xylitol-containing chewing gum use and optimal dosage during pregnancy.

Evaluating Wearable Smart Sensors for Continuous Measurement of Vital Signs in ICU Patients

The purpose of this study is to develop biocompatible wireless electronic devices that will allow continuous, non-invasive hemodynamic and physiology measurements in the ICU.

Eye Tracking and Autism in Former Preterm Infants

This is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP). Eligible participants referred for autism testing through EYP will undergo a traditional comprehensive diagnostic assessment by an EYP clinical psychologist.

The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants

Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention/silence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care.

Severe Intrauterine Growth Retardation: Developmental Newborn Intensive Care Unit (NICU) Care

The purpose of the study is to learn more about the development of small for gestational age (SGA) preterm infants and whether focusing on the infant's behavior has a positive effect on outcome. The study hypotheses state: 1) High risk severely SGA preterm infants will profit from detailed neuropsychological assessment, psychoeducational recommendations and practical guidance for caregiving, as well as formal educational and emotional support for the family and the professional care team. 2) Neuropsychological education and guidance for community-based early intervention providers caring for SGA preterm infants after their discharge is effective in promoting improved outcome.

Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants

Preterm infants frequently require non-invasive ventilation (NIV) to treat respiratory distress after birth. The effectiveness of NIV may be influenced by the interface used to deliver respiratory support. Nasal cannula and single nasal prong are two interfaces commonly used for NIV; however, evidence directly comparing their efficacy during the early postnatal period remains limited. This randomized controlled trial aims to compare the efficacy of a nasal cannula and a single nasal prong as interfaces for non-invasive ventilation in preterm infants after birth. Eligible preterm infants requiring NIV after initial stabilization will be randomly assigned to receive respiratory support using either a nasal cannula or a single nasal prong. The assigned interface will be maintained for one hour following randomization, including during transport from the delivery room to the neonatal intensive care unit. The primary outcome is the need for endotracheal intubation within one hour after interface application. Secondary outcomes include the need for endotracheal intubation within 6 hour of age, respiratory effectiveness, assessed by the oxygen saturation index (OSI) and arterial blood gas parameters (pH and partial pressure of carbon dioxide \[pCO₂\]), as well as interface-related adverse events, including interface dislodgement and nasal injury. This study is expected to provide evidence to support the selection of an effective non-invasive ventilation interface for preterm infants after birth.

VIPPSTAR-G1 Digital Early Intervention for Visual Impairment

Visual impairment in infancy is associated with significant risks for neurodevelopmental impairment. Early intervention based on enriched visual and multisensory experiences may promote neuroplasticity and improve developmental outcomes, but implementation of intensive interventions in routine clinical practice remains challenging. The VIPPSTAR-G1 study evaluates a caregiver-mediated digital intervention delivered through a dedicated platform designed to support visual and neurodevelopmental functions in infants at risk of or with visual impairment, within a framework that promotes and strengthens the parent-child/caregiver-child relationship. This multicenter, multinational, single-blind randomized controlled trial will enroll 102 newborns at risk of visual impairment and an additional exploratory pilot subgroup of 48 infants and toddlers with established visual impairment. Participants will be randomized to receive either the VIPPSTAR digital intervention plus standard care or standard care alone. Outcomes include visual acuity, smooth pursuit, additional neuro-ophthalmological functions, neurodevelopmental measures, adaptive functioning, language development, parental stress, quality of life, and feasibility of the digital intervention.

Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants

In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.

Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial

The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.

Circadian Feeding and Reciprocal Scent Intervention in NICU

Objective: This study evaluated the effects of circadian-aligned feeding and reciprocal scent intervention on premature infants receiving mechanical ventilation and on postpartum depression levels in their mothers. Methods: In this randomized controlled trial, 75 premature infants and their mothers were assigned to reciprocal scent, circadian feeding, or control groups (n=25 each). Interventions were applied for 21 days. Outcomes included time to weaning from mechanical ventilation, weight gain, hydration status, breast milk production, and maternal Edinburgh Postnatal Depression Scale (EPDS) scores.

Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants

The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births (delivered in maternity units with on-site neonatal intensive care). This project aims to assess the effect of the neonatal transport team (NNT) antenatal versus postnatal positioning on outborn survival without major neurodevelopmental sequelae at two years of corrected age (CA). A national, multicenter, observational cohort will be established over a two-year period, including all outborn births between 23+0-28+6 weeks' gestation in mainland France for which a NNT is deployed and who are alive at the moment of arrival of the NNT. 627 infants born outborn and their families will be followed until the child reaches two years of corrected age. Study will examine quality of neonatal resuscitation, stability during transport, neonatal morbidity, parental mental health and quality of life, medico-economic outcomes for both families and the healthcare system and regional provision of care. If parents agree to participate after receiving appropriate information, hospital records will be used to collect maternal and neonatal characteristics as well as morbidity data. Telephone follow-up will be conducted one month after discharge and then every six months until 2 years of corrected age (CA). Neurodevelopment at 2 years of corrected age will be assessed using the ASQ-3, completed by the parents. Through a detailed understanding of the processes of resuscitation, stabilization and transport, our goal is to reduce unnecessary deaths and disability for children and families, including long-term economic costs. The recommendations for the care of outborn preterm infants and for the optimization of NNT resources will be developed.

Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants

In this phase II trial, the investigators overarching goal is to demonstrate the feasibility and potential benefit of darbepoetin (Darbe) plus slow-release intravenous (IV) iron to decrease transfusions, maintain iron sufficiency and improve the neurodevelopmental outcomes of preterm infants. Investigators hypothesize that in infants \< 32 completed weeks of gestation, combined treatment with Darbe plus Ferumoxytol (FMX) or Darbe plus low molecular weight iron dextran (LMW-ID) will: 1) be safe, 2) decrease or eliminate transfusions, 3) maintain iron sufficiency, 4) result in higher hematocrit and 5) improve neurodevelopment. Investigators further hypothesize that when compared to oral iron supplementation (standard care), IV iron will be better tolerated, with less effect on the gastrointestinal (GI) microbiome

Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy

Medically tailored groceries (MTG), involving grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan, is a growing approach adopted by healthcare systems to address food insecurity in their patient populations, a leading contribution to health disparities such as poor birth outcomes within pregnant populations. However, transportation and other social needs can often hinder patient uptake of clinic-based approaches. Findings from this study will help to better understand how home delivery of MTGs, with and without supplemental education and support to improve food literacy, behavioral and health outcomes.

Non-Invasive Ventilation Interfaces and Nasal Pressure Injury in Preterm Infants

The goal of this randomized controlled clinical trial is to learn whether different non-invasive ventilation interfaces can prevent medical device-related nasal pressure injury in preterm infants receiving respiratory support in a neonatal intensive care unit. The main questions it aims to answer are: * Do different non-invasive ventilation interfaces affect how often nasal pressure injury develops? * Do these interfaces affect the severity of nasal pressure injury and the condition of the nasal skin? Researchers will compare three types of non-invasive ventilation interfaces (binasal prong, nasal cannula, and nasal mask) to see if one method is more effective in reducing nasal pressure injury. Participants will: * Be randomly assigned to one of three groups (binasal prong, nasal cannula, or nasal mask) * Receive non-invasive ventilation support using the assigned interface for at least 4 days * Have their nasal skin assessed every 12 hours for 96 hours using standardized scales * Continue to receive routine care in the neonatal intensive care unit

The Impact of Extreme Environmental and Security Conditions on Prematurity and Low Birth Weight Rates

Numerous reports indicate that various extreme environmental and security-related situations during pregnancy may increase the risk of prematurity, LBW, and miscarriage, as these events increase both the incidence and intensity of maternal stress. Study Objective: To map and validate this phenomenon within the catchment area of the Hillel Yaffe Medical Center.

The EveryPrem Project: Evaluating the INTER-NDA for Standardized Neurodevelopmental Screening at 2 Years of Age for Children Born Preterm.

Neurodevelopmental follow-up of infants at high-risk such as preterm born is necessary in order to early detect impairments and early start a supportive/therapeutic intervention. Valid tools should be available for screening infants with developmental problems even where resources are limited. Such screening would ensure an adequate medical care during and after hospital discharge as well as evidence-based parental pre- and postnatal counselling. While in Switzerland, these tools are specifically needed for the neurodevelopmental surveillance of moderate to late pretem born infants, in low- and mid-income countries, they are needed to monitor the whole population of preterm born infants. To fill this important gap, the present study aims to determine whether it is feasible to extend neurodevelopmental screening (currently offered to only a very small part of children born preterm), by using a new cost-effective neurodevelopmental assessment, the INTERGROWTH-21st Neurodevelopment Assessment (INTER-NDA, www.inter-nda.com Assessment) at age 2 years.

The Impact of Music Medicine on Preterm Brain Development and Behavior

The investigators are conducting a two-site randomized control trial with the aim of defining the impact of music (M) without or with parent voice (MPV) on very preterm infants' acute and cumulative stress, intranetwork connectivity on term brain MRI, and language and other neurodevelopmental outcomes at two years corrected age. This is based on the hypothesis that infants in MPV arm are expected to experience the greatest benefit compared with infants receiving standard care.

Effects of a Parenting Skills Training Program on Maternal Self-Efficacy, Perceived Social Support, and Infant Development in Mothers of Preterm Infants Aged 6-12 Months

The goal of this clinical trial is to evaluate whether a structured parenting skills training intervention can improve maternal parenting self-efficacy, perceived social support, and infant developmental outcomes in mothers of preterm infants aged 6-12 months (corrected age). The main questions it aims to answer are: Does a parenting skills training intervention improve maternal parenting self-efficacy? Does the intervention increase mothers' perceived social support and positively influence infant developmental levels? Researchers will compare mothers who receive the parenting skills training intervention with a control group receiving standard care to determine whether the intervention leads to greater improvements in maternal and infant outcomes. Participants will: Complete baseline, post-intervention, and follow-up assessments of parenting self-efficacy and perceived social support Have their infants assessed using standardized developmental evaluation tools Participate in a structured, home-based parenting skills training program consisting of multiple sessions (intervention group only) Take part in semi-structured interviews before and after the intervention to share their experiences and perceived needs

Post-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU)

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.

Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants

The research concerns the study of the interprofessional reproducibility of a grid for observing the development of premature infants from 1 to 6 months corrected age. No tool is available to characterize the mechanisms of early developmental processes and their deviations. We propose an analytical observation grid of developmental mechanisms in the first few months, in order to identify warning signs of developmental deviations and help define the nature and type of early care for vulnerable infants.