Clinical Research Directory

Fecal Calprotectin in Breastfed vs Formula-Fed Preterm Infants and NEC

This prospective observational study aims to evaluate fecal calprotectin levels as an early indicator of necrotizing enterocolitis in preterm infants and to compare levels between breastfed and formula-fed preterm infants at Assiut University Children Hospital.

The Effect of the Message Left by Mothers Whose Babies Are in the Neonatal Intensive Care Unit

Newborn babies may need to stay in neonatal intensive care units (NICU) immediately after birth for many reasons such as premature birth, low birth weight, respiratory distress, infection, jaundice. Depending on the cause and level of the newborn's illness, the length of stay may be extended, lasting weeks or even months. This situation negatively affects mother-infant bonding, causing mothers to be unable to establish healthy communication with their babies. For mothers in particular, leaving their babies in the NICU makes them feel inadequate and hopeless. Attachment is the emotional bond that a baby establishes with its mother or the person who cares for it. This bond established between the mother and the baby affects the emotional, social, cognitive and moral development of the individual throughout their life. It is known that secure attachment contributes to the physical and mental development of babies, while insecure attachment is associated with various mental illnesses. For these reasons, it is important to initiate secure attachment between the mother and the baby during the neonatal period. The aim of this planned study is to examine the effect of the messages left by mothers whose babies are in the NICU on mother-infant bonding and the mothers' level of hope. Mothers leaving messages for their babies provides a context in which they can express themselves to their babies and may positively affect mother-infant bonding and the mother's level of hope in the NICU.

The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants

Pain, defined by the International Association for the Study of Pain as a subjective, sensory, and emotional experience, differs from nociception, which is merely a neural activity. Premature newborns, whose inhibitory fibers are not yet mature due to anatomical and physiological development and who have insufficient endogenous opioid release, experience painful stimuli much more intensely. The inability of this age group to verbally express pain makes the diagnosis, assessment, and management of pain entirely dependent on healthcare professionals. Pain that is not effectively managed leads to stress and loss of comfort in the short term, while in the long term it can cause permanent neurodevelopmental problems and alter the individual's pain threshold later in life. Premature infants, especially those in Neonatal Intensive Care Units (NICUs), are exposed to invasive procedures that cause moderate to severe pain, such as heel prick tests, much more frequently than healthy term infants. In this context, pain management is a fundamental and essential nursing responsibility for the infant's neuroprotective developmental care. The literature shows that various non-pharmacological methods, such as oral sucrose, non-nutritive sucking (NNS), facilitated flexion, and wrapping, are used to alleviate pain during interventional procedures. Although more readily available in NICUs, studies on the effectiveness of oral glucose solutions are more limited compared to sucrose. This research, designed to address this gap in the existing literature, aims to investigate the effect of "oral breast milk, 20%, and 10% dextrose solution administered with supportive positioning methods" on pain reduction during heel prick blood sampling in premature newborns. The results of this research are expected to contribute to the development of a new, easily applicable, effective, and evidence-based nursing intervention strategy for NICUs.

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.

Automated Oxygen Control in Preterms on Non-invasive Ventilation

This randomised controlled trial aims to investigate the effectiveness of closed-loop automated oxygen control (CLAC) in preterm infants receiving non-invasive respiratory support and determine if it reduces the duration of supplementary oxygen treatment and improves achievement of oxygen saturation targets, reduces the incidences of hypoxia and hyperoxia, the number of manual adjustments to the inspired oxygen concentration (FiO2), and adverse outcomes including bronchopulmonary dysplasia (BPD). The study will take place at King's College Hospital neonatal intensive care unit (NICU). Parents of preterm infants born at less than 34 weeks of gestation and receiving non-invasive respiratory support will be approached, informed and if appropriate consented to join the trial. Participants will be randomised to receiving either automated or manual oxygen control. The study will measure outcomes including the duration of supplementary oxygen treatment, the percentage of time spent within oxygen saturation targets, the incidences of hypoxia and hyperoxia, the number of manual FiO2 adjustments required, the overall duration of non-invasive respiratory support and length of neonatal unit stay, and the incidence of BPD at 36 weeks postmenstrual age (PMA). Results will be compared between the two groups.

Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants

Preterm infants are at increased risk of vitamin A deficiency because they are born with low vitamin A stores and depend largely on breast milk to meet their nutritional needs. This study will evaluate whether daily maternal vitamin A supplementation increases vitamin A concentrations in the breast milk of mothers who deliver infants before 29 weeks of gestation. Participants will receive a commercially available oral multivitamin supplement containing 1,300 mcg retinol activity equivalents (RAE) of vitamin A daily for four months after delivery. Breast milk samples will be collected at 2 weeks, 2 months, and 4 months postpartum to measure vitamin A concentrations. The study will assess whether maternal supplementation is a feasible approach for increasing breast milk vitamin A concentrations in mothers of preterm infants.

The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns

Premature infants frequently experience painful procedures during their admission to neonatal intensive care units; this can lead to acute adverse events, imbalances, and long-term neurodevelopmental implications. This randomized controlled trial evaluates the impact of Gentle Human Touch (GHT) and rate change (eye mask and earplug) on pain and comfort during heel prick blood collection in premature infants (32-36+6 weeks gestational age). A total of 60 infants were randomly assigned to three groups: GHT, rate change, and standard care (pacifier). Pain was assessed using the Premature Infant Pain Profile-Revised (PIPP-R), and comfort was measured before, during, and after the procedure using the COMFORTneo operator. Physiological impact (heart rate, oxygen saturation) and propagation time were recorded. The findings provide evidence for safe and effective non-pharmacological interventions in pain management and their inclusion in developmental care protocols.

Impact of Prematurity on the Optic Nerve

The purpose of this protocol is to study the consequences of prematurity on the optic nerve. Indeed, the work already carried out on the subject suggests that prematurity induces suffering of the optic nerve with a loss of optical fibre, an essential element in the transmission of the visual nerve signal to the brain. The investigators will therefore study two populations: a population of premature infants aged 5 to 10 years, and a control population of term infants. The examinations performed are painless, non-invasive and non-irradiating. To date, there are no known adverse reactions to these tests. These examinations are a photo of the fundus (retinophotography), a pachymetry (measurement of the thickness of the non-contact cornea), an OCT RNFL (optical coherence tomography, scanner of the non-irradiating non-painful optical nerve) and the taking of the IOP (intraocular pressure). They aim to measure the main morphological characteristics of the eye and the optic nerve. This is a prospective observational study. The inclusion and measurements necessary for the study are made on the day of the consultation. The expected results will provide new data on this population of premature infants, allowing for better management if a pathology involving the optic nerve were to occur at any age in these patients.

Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial

Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.

Gut Bacteria and Brain of the Baby

The project is a prospective French population based cohort. A hundred moderate preterms born at GA30-326/7 will be enrolled for a longitudinal follow-up up to 2 years of corrected age. Eligible neonates will be those born at 30-326/7 weeks of gestation admitted to the neonatal intensive care unit of Rennes Hospital, including transferred infants during the first day of life. The infants will be followed up to the corrected age of 2 years by pediatricians.

Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates

Respiratory morbidity presents a significant clinical challenge in the neonatal period, and an individual patient's clinical course is often difficult to predict. This is especially true for late-preterm infants, who share some of the same risks of premature babies in terms or respiratory morbidity, but whose births may not always be attended by a neonatologist, or who may be born at hospitals with lower level Neonatal Intensive Care Units (NICUs) and require transfer if they decompensate. With this study, the aim is to 1) determine the efficacy of early point of care lung ultrasound (LUS) to predict respiratory decompensation in the first 48 hours of life in late preterm infants and 2) to compare the performance of three lung ultrasound scoring systems, 3 type-of-lung, high risk pattern and total LUS scoring systems.

Effect of Rectal Administration of Breast Milk on Gut Microbiota in Preterm Infants

This study aims to evaluate the effect of rectal administration of maternal breast milk on gut microbiota development in preterm infants. Preterm infants are at increased risk of dysbiosis due to immaturity and limited enteral feeding in the early postnatal period. In this randomized controlled study, preterm infants will receive either rectal administration of maternal breast milk or normal saline. The primary objective is to compare gut microbiota composition between the two groups. The findings may provide insight into a novel and non-invasive strategy to support microbiota development in preterm infants.

Effect of Teach-Back Education on Breastfeeding and Bonding in Mothers of Preterm Infants

The aim of this randomized controlled experimental study is to contribute to the standardization of nursing interventions for premature mothers and to establish a scientific basis for breastfeeding education models in our country. It also aims to evaluate the effects of the following: digital privacy literacy, children's autonomy, decision-making ability, and privacy awareness. The hypotheses of the study are as follows: H₁: Mothers who received Teach-Back training have a higher level of breastfeeding self-efficacy. H₂: Mothers who received Teach-Back training have a higher level of mother-infant bonding. H₀: There is no significant difference between the groups.

Reactions to Oro-facial Solicitations : a Predictor of Eating Difficulties for Premature Babies of 36 Weeks Gestation Adjusted Age

The goal of this observational study is to assess the link between reactions to orofacial stimuli observed at 29 weeks of amenorrhoea, and feeding difficulties at 36 weeks of amenorrhoea, in babies born prematurely between 26 and 27 + 6 weeks of gestation, admitted to the CHSF between 1 May 2025 and 31 March 2026. The main questions it aims to answer are : Can reactions to orofacial stimulation in babies born very prematurely be used as a tool for early detection of feeding difficulties before discharge from hospital? Is it possible to establish a predictive score for potential feeding difficulties as early as 29 weeks of gestation corrected, based on reactions to orofacial stimuli ? Participants will have their reactions to orofacial stimulations recorded in the 'Suivi oralité' grid completed by the nurses in the neonatal medicine and intensive care unit, which will then collect.

Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants

This study compares three approaches to help premature babies learn to feed by mouth: a special mouth exercise program (called PIOMI), using a pacifier, and standard care. Premature babies often have difficulty feeding because their sucking, swallowing, and breathing are not yet coordinated, which can lead to longer hospital stays. The study will include 150 premature infants born between 26 and 32 weeks of pregnancy at a hospital in Thi Qar. Babies will be randomly placed into one of three groups: one group will receive a many-day mouth exercise program, another will use a pacifier for many days, and the third will receive routine care. We will measure how quickly each baby learns to feed fully by mouth, how long they stay in the hospital, how much weight they gain, and their feeding skills. The results may help improve care for premature babies and reduce the time they spend in the hospital.

Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates

This study aims to study the effect of lactase enzyme in preventing feeding intolerance in preterm neonates in neonatal intensive care unit at Alexandria University Children's Hospital.

Evaluation of Placental Transfusion Techniques in Prevention of Prematurity Related Complications and Effect on Their Hematological Profile

The objective of this study is to evaluate the general course and prognosis associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life

Pain and Comfort in the Examination of Retinopathy of Prematurity

This study is planned to be conducted in the Neonatal Intensive Care Unit using a double-blind, parallel-group, randomised controlled design to determine the effect of a pacifier dipped in breast milk on pain and comfort during Retinopathy of Prematurity examinations. The study will be conducted in the Neonatal Intensive Care Unit of a University Hospital in Erzurum. The sample for the study will consist of preterm infants born before 32 weeks of gestation who are receiving treatment and care at the clinic during the study period and who meet the study criteria, without using any sampling method. The power analysis for sample size indicated that at least 36 infants should be included in the study, with 18 infants in each of the experimental and control groups. The control group will undergo ROP examination in accordance with standard clinical procedures. All examinations will be performed by the same ophthalmologist. Infants in the experimental group will be fed with a pacifier dipped in breast milk, starting two minutes prior to the examination, by the same clinical nurse responsible for the infant's care, and feeding will continue until the examination is completed. Video recordings will be taken of all infants from two minutes prior to the start of the examination until two minutes after the examination. In both groups, data will be monitored and recorded using the Preterm Infant Pain Profile-Revised (PIPP-R), the Preterm Infant Comfort Scale (COMFORT neo), and vital signs before the ROP examination begins, during the examination, and after the examination.

Baby ABS (Abdominal Binder Study)

The primary outcome of this study is to determine if the use of the FDA-approved DandleLion NeoBellyBand increases the thickness of the rectus abdominis muscle in premature babies receiving continuous positive pressure ventilation, leading to infants reaching full oral feedings at an earlier corrected gestational age.

Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants

A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.

Triglycerides Glucose Index on Angiographic Profiling of Non-Diabetic Premature Coronary Artery Disease Patients

This study aims to evaluate the impact of the triglyceride-glucose (TyG) index on the angiographic profiling of non-diabetic patients with premature coronary artery disease (CAD).

Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions

Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child. However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown. PREMIAM study investigates whether active parental participation in enteral nutrition improves the interactions between the infant and his parents, making them more sensitive to their baby's signals and promoting their relational adjustment.

Post-extubation Use RAM Cannula Versus Short Binasal Prong Interfaces in Preterm Infants

Nowadays, the use of non-invasive ventilation for preterm infants in the NICU has increased to avoid complications associated with prolonged endotracheal intubation. Adequate pressure delivery through non-invasive ventilation is essential, as it enhances the growth and development of premature lungs. Various interfaces have been used to ensure proper sealing. The RAM cannula, used as an interface for non-invasive respiratory support in preterm neonates, is associated with reduced nasal trauma compared to short binasal prongs (SBPs), due to its softer material, making it a safer option. However, the RAM cannula has been shown to deliver lower pharyngeal pressure and, therefore, may not maintain airway pressure as consistently as nasal prongs. Currently, limited data is available regarding the efficacy of nasal prongs compared to the RAM cannula as a post-extubation interface for non-invasive ventilation support in preterm infants. Additionally, we have observed that the use of the RAM cannula for non-invasive ventilation in preterm infants is associated with a longer duration of oxygen therapy compared to SBPs. The investigators hypothesize that the RAM cannula provides a lower level of positive end-expiratory pressure compared to SBPs during non-invasive ventilation. The investigators aim to assess the efficacy and safety of the RAM cannula versus SBPs as nasal interfaces for post-extubation non-invasive respiratory support in preterm infants.

Magnetoencephalography by Optical Pumping Magnetometer

MagnetoEncephaloGraphy (MEG) is a method of recording brain activity with high temporal resolution and good spatial resolution, compared to current recording techniques such as ElectroEncephaloGraphy (EEG). The main limitation of MEG is its cost due to the sensors used, the Super Quantum Interference Devices (SQUID). These require a complex infrastructure from an instrumentation point of view to operate, requiring liquid helium, most often at a loss, at increasing cost. Optical Pumping Magnetometers (OPM) type sensors represent a promising alternative to SQUIDs sensors, especially since they do not require helium cooling. The purpose of this project is to Identify biomarkers in Magnetoencephalography of normal brain development in healthy adults, premature and term newborns from "a priori" obtained by the classical technique of High Resolution EEG performed.