Clinical Research Directory

Rectal Administration of Mother's Own Milk and Growth in Preterm Infants

This retrospective observational cohort study evaluated whether rectal administration of mother's own milk was associated with feeding progression and growth in preterm infants. The study included 50 infants born between 27+0 and 32+6 weeks of gestation at a neonatal intensive care unit in Baku, Azerbaijan, between January 2023 and January 2026. All infants had delayed meconium passage beyond 48 hours after birth. Of the 50 infants, 29 received rectal administration of mother's own milk as part of clinical care, while 21 did not receive this intervention. Treatment was not randomly assigned. The primary outcome was time to full enteral feeding. Secondary outcomes included time to full oral feeding, hospital stay, and weight, length, and head circumference at 36 and 40 weeks' postmenstrual age. The study aimed to explore whether this clinical practice was associated with improved feeding and growth outcomes and to provide preliminary evidence for future clinical trials.

Maximising Maternal Milk for Preterm Infant

Maternal milk is the gold standard in infant nutrition, providing significant advantages, in preterm and term infants. Maternal milk plays a major role in reducing the risk of inflammatory bowel disease(NEC) in premature and low birth weight infants as well as improving neurodevelopmental outcomes in this population, In this study the investigators are comparing earlier (from birth rather than 48 hours post delivery) use of an electrical breast pump. Mothers will be selected at random to be in one of two groups: early or later pump use. The investigators will compare milk volumes achieved on day 14 post delivery between the two groups. The investigators will recruit x number of mothers of preterm infants \< 33 weeks gestation at birth

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.

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.

Effect of Automated Oxygen Control on Early-childhood Lung Mechanics

Preterm infants are at higher risk of long-term respiratory problems and abnormal lung function in childhood. Respiratory support including mechanical ventilation, that is the use of a machine to move air into and out of the lungs, and oxygen treatment may further increase the risk of complications. In a randomised controlled trial, closed-loop automated oxygen control (CLAC) was associated with reductions in the duration of mechanical ventilation and oxygen treatment and may, therefore, help reduce long-term respiratory morbidity. The effect of CLAC systems on lung function has not been explored to date. This prospective observational study aims to explore the effect of automated oxygen control during the neonatal period on lung mechanics in children who were born at less than 34 weeks of gestation and required mechanical ventilation. The study will take place at King's College Hospital (KCH) children's outpatient department. Parents of children that participated in the randomised trial of automated versus manual oxygen control will be approached, informed and if appropriate consented to join the study. The study will measure outcomes including lung mechanics and parent-reported respiratory morbidity (breathing difficulties, respiratory infections, hospital admissions after discharge from neonatal care). Results will be compared between the two groups. Lung mechanics will be assessed using a technique called forced oscillation. This is a technique which involves the patient breathing through a face mask (if less than two years of age) or a mouthpiece filter (if older than two years). It is a non-invasive technique that measures lung function by superimposing gentle air pressure waves onto the patient's spontaneous breathing.An average of three measurements each one lasting up to 20 seconds will be performed. Parents will be asked to fill in a questionnaire regarding the health of their child after discharge from the neonatal unit. The study's duration will be 12 months.

Lactase-Assisted Control Trial On Weight GAin in INfants.

Lactose, a disaccharide that includes the monosaccharides glucose and galactose, is the main carbohydrate found exclusively in mammalian milk. Lactase is found in the intestinal mucosa and is located at the ends of the villi, while it is a factor of maximum clinical importance in milk tolerance and in the occurrence of diarrheal disease. Developmental lactase deficiency is defined as the relative lactase deficiency observed in premature newborns less than 34 weeks of gestation. In the immature gastrointestinal tract, lactase and other disaccharidas are deficient until at least 34 weeks of gestation. One study in premature babies reported a benefit from the use of lactase-supplemented or lactose-reduced formulas, while the use of lactose-containing formulas and human milk did not appear to have short- or long-term harmful effects on infants and infants. Up to 20% of dietary lactose can reach the colon in newborns and young infants. Due to the inadequate functional development of lactase, premature infants may not digest and absorb the main source of carbohydrate energy, lactose. The high osmotic load associated with indigestible lactose is one of the many possible causes of diarrhea and food intolerance in premature babies. As a result of diarrhea stools and small bowel damage, the already low functional activity of lactase will be further reduced affecting weight gain, while it takes up to 2 weeks for lactase activity to be restored. Carlson et al showed that the addition of lactase to premature formula reduces the amount of lactose by 70%, with a negligible effect on osmolarity. Previous studies have found that premature infants fed a reduced lactose formula had a better weight gain rate than those who took 100% lactose formula. In two of these studies, weight gain improved despite eating fewer calories. In the present study we intend to test whether the use of lactase to hydrolysis lactose in premature milk would result in better weight gain and improved dietary tolerance by taking the same calorie intake. This is a prospective, randomized controlled trial with caregivers and investigators responsible for outcome analysis and interpretation masked to treatment allocation to evaluate feeding tolerance and weight gain in preterm infants receiving either (1) human milk or preterm formula supplemented with lactase (intervention group) or (2) human milk or preterm formula without lactase supplementation (non-intervention group). The study will be carried out at the Second Neonatal Clinic and Neonatal Intensive Care Unit of the Aristotle University of Thessaloniki, in premature newborns (gestational age \[GA\] 28-34 weeks) who will be hospitalized in the Neonatal Intensive Care Unit. The study will enroll newborns (1) with a gestational duration of 28 to 34 weeks, (2) who receive ≥75% of their energy needs intestinally, (3) with the absence of severe congenital malformations or gastrointestinal diseases, including necrotizing enterocolitis (NEC) (4) without taking postnatal steroids or diuretics at the time of eligibility assessment. Small, suitable and large for newborns of gestational age will be eligible for the study. Exclusion criteria will be neonates whose guardians refuse to participate in the study, neonates with congenital malformations or gastrointestinal diseases, and neonates receiving postnatal steroids or diuretics. The participation of newborns in the study will take place after written consent of the parents after information.

Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1. Do preterm infants who sleep in the SNOO have more quiet sleep? 2. Do preterm infants who sleep in the SNOO have improved vital signs? * Participants will spend two separate three-hour periods sleeping in either a SNOO (which plays white noise and rocks from side-to-side) or in a SNOO that remains off (does not play white noise and does not move). There will be at least one week separating these sleep assessments. * Participants will have their sleep stage and vital signs monitored (heart rate and oxygen levels). * Participants will also wear two stickers on their forehead that measure brain oxygen levels (NIRS) and brain waves (EEG). There is a chance that the infant may experience more restful sleep and improved vital signs during the 2 sleep assessments.

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.

Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP) respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP without oscillations. This will be measured by need for change to ventilator support, improvement in pCO2 values, and reduction in respiratory rate and frequency of apnea during the period of NCPAP treatment. Other respiratory outcomes will also be compared, including time on NCPAP, time on High-Flow Nasal Cannula support following NCPAP, and time-averaged PiO2 from start of study to end of respiratory treatment.

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.

HEP® Delivered Via Telerehabilitation for Preterm Infants With Developmental Risks

Preterm infants are at increased risk for developmental delays, making early intervention essential for optimizing developmental outcomes. This study aims to evaluate the effectiveness of the Homeostasis-Enrichment-Plasticity (HEP®) approach delivered via telerehabilitation in preterm infants at risk for developmental delay. Eligible preterm infants will be randomly assigned to either the HEP® telerehabilitation group or the control group receiving usual care. The intervention will be delivered over 12 weeks through weekly online sessions combined with parent coaching and individualized home-based activities. The study will evaluate the effects of the intervention on infant development, sensory functions, goal attainment, and parental well-being. The findings may provide evidence for the use of family-centered telerehabilitation as an early intervention strategy for preterm infants at developmental risk.

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.

Maternal Odor as a Developmental Care Intervention for Apnea of Prematurity

Apnea of prematurity is one of the most common complications in preterm infants hospitalized in neonatal intensive care units. This randomized controlled trial was conducted to evaluate the effect of maternal odor exposure as a developmental care intervention on apnea frequency, physiological parameters, and growth outcomes in preterm infants. Sixty preterm infants were randomly assigned to either a maternal odor intervention group or a routine care control group. The intervention group received maternal odor using a cotton cloth carrying the mother's natural scent for five consecutive days. The primary outcome was the daily number of apnea episodes. Secondary outcomes included oxygen saturation, heart rate, respiratory rate, body temperature, weight, and head circumference.

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.

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.