Clinical Research Directory

NIRS Monitoring in Premature Infants

This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for newborns with germinal matrix-intraventricular hemorrhage (GM-IVH) and/or post-hemorrhagic hydrocephalus (PHH) in comparison to newborns with hydrocephalus of a different etiology (VC) and healthy controls (HC). We hypothesize that baseline cerebral metabolic dysfunction is a better biomarker for GM-IVH and PHH severity and response to PHH treatment. This is a Boston Children's Hospital (BCH)-institutional review board(IRB) approved, multi-site study that includes collaboration with Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC). Pei-Yi Lin receives funding from The National Institute of Health (NIH) to support the study and is the overall principal Investigator (PI) overseeing the study.

The China Neonatal Genomes Project

The project will carry out the genetic testing of 100000 neonates in the next 5 years. The aim of the project is to construct the Chinese neonatal genome database, establish the genetic testing standard of neonatal genetic diseases, and promote the industrialization of neonatal genetic disease gene testing, improve the training system for genetic counseling.

The Effect of Skin-to-Skin Contact Based on Clinical Guidelines

Newborn health indicators are important data that provide information about the welfare level of countries. Health professionals and relevant institutions have important responsibilities in protecting, developing and ensuring the continuity of newborn health. Health professionals use evidence-based practices revealed by scientific studies in their care approaches. Care and follow-up immediately after birth are very important. When the investigators look at the neonatal mortality rate in our country in 2019, it is shown as 5.3 per thousand and 5 per thousand in 2020. Therefore, neonatal-specific programs and practices need to be strengthened in order to reduce both neonatal and postneonatal death rates. Midwives are the professional group that is with both the mother and the newborn during the birth and postpartum period, can initiate breastfeeding in the early period, and ensure optimal continuation of breastfeeding. It is very important that the basic health indicators of the newborn improve and that the mother and newborn are monitored at certain standards during and after birth. These monitoring must be done according to the criteria. Genç et al. in 2022 to initiate and maintain skin-to-skin contact with the newborn during the postpartum period. (2023) skin-to-skin contact will be made between the mother and the newborn in accordance with the "Skin-to-Skin Contact and Kangaroo Care Clinical Practice Guide".

Impact of Prepartum Intravenous Fluid Intake on Newborn Weight Loss in the First Days of Life

At birth, the infant's weight was measured daily to assess the adequacy of nutritional intake. This indicator can be influenced by various factors related to the mother, her pregnancy, as well as medical interventions during the pre-delivery phase, such as pre-partum maternal fluid intakes, and the subsequent feeding method chosen for the newborn infant. This study aimed at exploring the association between maternal vascular fluid loading during labor in the pre-partum period and neonatal weight loss in the first two days of life. The study focuses on infants fedded with infant formula. This observational, retrospective, single-center study was carried out at the Amiens University Hospital Center. The participants were mothers aged 18 and older, hospitalized in the maternity ward following full-term delivery (\> 37 weeks of gestation). Data were collected through the medical records of the patient and their newborn. The investigators hypothesize that a relationship may exist between maternal pre-partum vascular fluid loading and neonatal weight loss in the first two days of life, in infants fed with infant formula. These results could raise awareness and help adapt medical and parental approaches to neonatal weight loss.

Improve the Survival Without Morbidity of Extremely Preterm Infants (PREMEX)

The intervention proposed is a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol, involving early, standardized, and multidisciplinary management of women hospitalized for a risk of extremely preterm birth and their children. It will take place in each perinatal network for all pregnant women hospitalized between 22 and 26 weeks with a risk of preterm delivery. Setting up the protocol requires taking into account the parents' time and timing issues, and its potential for change, to plan the implementation of the protocol, especially the degree of emergency of the situation and the probability of imminent delivery. The follow-up collected for this study will take place: * At D4 post-delivery: A questionnaire about the parents' experience of the information delivered and the decisions made will be given to and collected from the parents * At Day 28, post-delivery: A questionnaire about the parents' experience of care for their child will be given to and collected from the mother and the co-parent. * At the child's discharge from the hospital, or if he or she dies in the hospital: * Collection of clinical data (principal endpoint) from data in the medical file. * Data to measure practices and adherence to the intervention will be collected * When the child reaches the corrected age of 2 years: * a short questionnaire will be completed by the physician caring for the child at the corrected age of 2 years. The data collected will concern motor and sensory development, in particular, cerebral palsy, blindness, and deafness.. * Information about the child's development will also be collected with a questionnaire including a standardized assessment scale, he PARCA-R questionnaire (Parent Report of Children's Abilities-Revides), which the parents will complete.

Validation of STARZ Score for Early Neonatal AKI

Neonatal acute kidney injury (AKI) is a common complication in the NICU, associated with high morbidity and mortality. Prematurity, low birthweight, sepsis, asphyxia, congenital heart disease, and nephrotoxic drugs are major risk factors. Early diagnosis is challenging as serum creatinine lacks sensitivity. The STARZ score, a composite clinical-laboratory tool, has shown high accuracy for predicting early neonatal AKI. This study aims to validate the STARZ score in neonates admitted to Assiut University Children's Hospital for early identification of AKI and improved clinical outcomes."

Effects of Music-Based Interventions on Sleep Patterns and Physiological Responses in Premature Newborns: A Systematic Review and Meta-Analysis

Sleep in the neonatal period is a fundamental biological requirement for regulating growth, neurodevelopment, and the immune system. However, disruptions in sleep patterns during this period are common among both term and preterm infants. Preterm infants have a more fragile sleep structure due to incomplete neurological maturation, while term infants may also experience sleep difficulties during the postnatal adaptation process. Improving sleep onset and sleep quality in newborns is crucial for the well-being and quality of life of both the infant and the family.

Pain and Comfort Levels During Heel Stick Blood Sampling in Newborns

Aim: The study was designed to determine the effect of Buzzy® and Shotbloker® application on pain and comfort levels in newborns during heel pricking. Method:The study was a randomised controlled trial. The study sample consisted of 159 newborns (Buzzy: 53, Shotbloker: 53, control: 53) who had heel pricks between March 2025 and December 2025 at the Samandağ State Hospital Neonatal Care Unit. The data collection tools used will be the Newborn Information Form, the Newborn Pain Scale, the Newborn Comfort Behaviour Scale, and the Buzzy® and Shotbloker® devices. In the intervention group, the Buzzy® and Shotbloker® devices will be applied before and after heel pricking, while the control group will receive routine care. The infants' pain and comfort levels will be assessed by the nurse before and after the procedure.

Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants

During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\'s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed. In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\'s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation.

Study on Early Genetic Screening and Precise Strategy of Neonatal Critical Illness

The researchers hope to establish an overall program of early genetic screening for neonatal critical illness in China, and to develop precise intervention strategies to assist clinical diagnosis and treatment of hereditary critical illness.

The Effect of Wiping Bath Training on Early Bathing, Body Temperature and Umbilical Cord Fall Time in Newborns

The aim of this study is to examine the effects of wiping bath training on early bathing, body temperature and umbilical cord shedding time in newborns. This study was planned in a randomized controlled experimental research design. The study will be conducted with pregnant women who applied to the pregnancy schools of Kahramanmaraş Necip Fazıl City Hospital Gynecology and Obstetrics Additional Service building. When calculating the sample size, a similar study previously conducted on the subject was taken as a reference and the G\*Power 3.1.9.7 program was used (Ayyıldız et al, 2015). In the calculation made; the sample size of the study was found to be at least 36, and considering the parametric distribution, it was planned to complete the study with a total of 60 people, 30 in each group. Considering the possible case losses (10%), it is planned to include a total of 66 women (intervention group: 33, control group: 33). In the study, women will be assigned to groups according to the previously determined randomization number sequences, and then the Pregnant Information Form will be filled out by the participants using the face-to-face interview method. The determined practices will be carried out according to the group to which the participants are assigned. The hospital's pregnancy information class will be used for the training, and if there is another planned training in the pregnancy school, an empty room determined by the hospital administration will be used. The pregnant women in the intervention group will be explained the newborn wiping and bathing application stages by the researcher in groups of 2-3 people on a newborn model, and then the pregnant women will be asked to apply the bath individually on the model. The pregnant women in the control group will be subject to routine hospital protocol and no other intervention will be made. After the birth, the participants will be called by phone and the "Newborn Characteristics Information Form" will be filled out by phone and the participants will be asked to provide information by phone message after the umbilical cord falls off. After the umbilical cord falls off, the participants will be called by phone and the first bath time, umbilical cord falling off time and the body temperature of their babies (before the bath, immediately after the bath and 10 minutes after the bath) will be recorded by asking the mothers on the given follow-up form.

Massage for Newborns Receiving Nasal CPAP

One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure (NCPAP) support through the nose. NCPAP application has many advantages but also disadvantages and complications. Gastric-abdominal distension, which is a complication of NCPAP application, is caused by gas entering the stomach and gastrointestinal tract. Feeding intolerance may develop in the newborn due to abdominal distension. In recent studies, it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress. These practices include therapeutic touch, mother's voice, fetal position, white noise, lullaby, wrapping and massage. In the literature, a quasi-experimental study examining the effect of massage (Field massage technique) on the respiration, heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation, but respiration and heart rate decreased after the massage. has been determined. There are studies in the literature examining the effects of therapeutic touch, mother's voice, fetal position, white noise, lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP, reduce stress and pain, and prolong sleep time. However, no research has been found in the literature examining the effects of massage on the stress, comfort and health parameters of newborns receiving nasal CPAP.

Comparison of Open and Closed Aspiration in Newborns

Endotracheal aspiration is a necessary procedure performed by nurses in neonatal intensive care units to increase oxygenation and remove secretions from the airways. It is one of the painful procedures that most frequently causes stress in intubated newborns.

Concept Map on Toxic Stress in Newborns

This study will be conducted as a single-blind randomized control group intervention trial to examine the effect of using concept maps on the students' knowledge levels about toxic stress in newborns, which is explained to second-year nursing students.

Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity

Metabolic bone disease of prematurity (MBDP) is caused by insufficient content of calcium, phosphorus, and organic protein matrix in preterm infants or bone metabolism disorder, which is one of the complications affecting the quality of life of preterm infants. The early symptoms of MBDP are insidious, and there is no unified and clear diagnostic method. The diagnosis is mostly based on typical clinical manifestations and X-ray findings, but at this time, bone mineral density has decreased significantly, so early detection and diagnosis are difficult. Studies have shown that exosomal micrornas have biological characteristics and targeting specificity, and can be used as new molecular diagnostic markers for diseases. Several studies have reported the use of plasma or serum microRNAs as molecular markers for early prediction of bone diseases. In our previous study, we extracted plasma exosomes from preterm infants for high-throughput sequencing of microRNAs, and identified differentially expressed micrornas related to bone metabolism. In this study, exosomes were used as carriers, and digital PCR was used to verify the specificity and sensitivity of plasma exosomal microRNA as biomarkers of MBDP in a large sample size. The above biomarkers were compared and verified before and after treatment in children with MBDP. Further revealing plasma exosomal microRNA as a biological indicator for evaluating the efficacy of MBDP may improve the diagnostic level of MBDP, improve the outcome and prognosis of very low birth weight preterm infants, thereby improving global health and reducing socioeconomic costs.