Newborn

12

Review clinical trials related to Newborn. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

The Effect of Pre-Breastfeeding Breathing Exercises on Maternal Anxiety, Well-being, and Infant Stress in Mothers Whose Infants Are in the Neonatal Intensive Care Unit

Aim: This study was conducted to examine the effects of breathing exercises on maternal anxiety, well-being, and infant stress. Materials and Methods: The research was initiated in a hospital in eastern Turkey between November 2024 and November 2026, after obtaining ethical committee and institutional approvals. The study population consisted of mothers whose babies were hospitalized in the neonatal intensive care unit (NICU) of that hospital.The generally available G\*Power 3.1.9.7 for Windows software was used to calculate the sample size. Similar literature studies were referenced when determining the sample size of the research (Shamsdanesh et al., 2023). Furthermore, after the research is completed, a post-hoc power analysis will be performed on the main dependent variable, maternal anxiety level (MAL), to determine the power of the study (approximately 35 experimental, 35 control). The aim of the research is to ensure that the resulting sample size has sufficient statistical power to reveal the effect being examined. The research data is collected using a Demographic Information Form, prepared by the researcher through a literature review, the State and Trait Anxiety Inventory, the Psychological Well-being Scale, and the Neonatal Stress Scale. Mothers perform this exercise three times a day for two days (days 1 and 2), under the supervision of a researcher. The four-square breathing exercise is a non-pharmacological pain reliever that has been shown to be beneficial in conditions other than pain. Each breathing exercise lasts 5-10 minutes. Mothers in the experimental group are given a questionnaire before the start of the study and after the exercise on days 1 and 2. Mothers in the control group are given only a questionnaire before the start of the study, at the end of day 1, and at the end of day 2. Mothers in the control group do not perform the four-square breathing exercise and receive routine hospital care. At the end of both days, mothers in the control group who wish to practice the breathing exercise are given the opportunity to do so.

Participants needed: 70
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Inonu UniversityUpdated: Jun 18, 2026Locations: 1
Eligibility criteria

Ability to communicate verbally, [+3]

Having a psychiatric diagnosis according to medical records, [+3]

Status: Recruiting

Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward

The quality of sleep in maternity wards is crucial for the mental and physical health of the mother, as well as for the development of secure mother to infant bonding. The introduction of "co-dodo" cribs, although scarcely studied, may influence sleep quality in both the mother and the newborn infant. Objective : This study aims at evaluating the impact of a co-dodo crib on the sleep quality of the newborn infant, her mother and the mother-infant bonding, compared to a control group with mother using a standard crib. This observational, randomized, controlled, multicenter study will include adult mother, breastfeeding and hospitalized in maternity wards after full-term delivery (≥ 37 weeks of gestation). Participant will be randomly assigned in a 1:1 ratio to receive either a co-dodo crib or a standard crib for their newborn infant during their maternity STAI-Y. Actigraphic data will be used for non-invasive sleep assessment in both the newborn infant and the mother. Validated self-reported questionnaires will evaluate maternal stress, sleep quality, post-partum depression risk and mother-infant bonding. • Hypothesis : We hypothesize that using a co-dodo crib compared to a standard crib may improve the newborn and mother sleep quality, decrease the mother stress and enhance the mother to infant bonding.

Participants needed: 132
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

Mother over 18 years of age; [+8]

Mother for whom a cesarean section is scheduled [+7]

Status: Recruiting

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.

Participants needed: 70
Trial details
Age: 0-12Biological sex: AllType: ObservationalSponsor: Boston Children's HospitalUpdated: Mar 18, 2026Locations: 3
Eligibility criteria

Not listed

Status: Recruiting

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.

Participants needed: 100,000
Trial details
Age: Up to 28Biological sex: AllType: ObservationalSponsor: Children's Hospital of Fudan UniversityUpdated: Mar 16, 2026Locations: 1
Eligibility criteria

1. Both parents are of Chinese origin; [+3]

1. the nationality of one of the parents is not the Han nationality or other nat... [+6]

Status: Recruiting

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.

Participants needed: 200
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: Nov 21, 2025Locations: 1
Eligibility criteria

Full-term delivery (≥37+0 SA) [+3]

Mother under guardianship [+7]

Status: Not yet recruiting

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."

Participants needed: 140
Trial details
Age: 0-28Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: Oct 2, 2025
Eligibility criteria

Neonates admitted to the NICU within 48 hours of birth. [+4]

Neonates with known congenital renal anomalies diagnosed antenatally or postnata... [+3]

Status: Not yet recruiting

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.

Participants needed: 1,415
Trial details
Age: 26-37Biological sex: AllType: ObservationalSponsor: Istanbul University - CerrahpasaUpdated: Aug 17, 2025
Eligibility criteria

Premature infants who are clinically stable and between 26 and 37 weeks' gestati... [+4]

Non-neonatal infants (aged over 28 days). Term infants (≥37 weeks). [+3]

Status: Recruiting

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.

Participants needed: 159
Trial details
Age: 1-1Biological sex: AllType: InterventionalSponsor: Tarsus UniversityUpdated: Jul 23, 2025Locations: 1
Eligibility criteria

The baby must be full-term (38-42 weeks), [+5]

The baby is not full-term, [+5]

Status: Recruiting

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.

Participants needed: 120
Trial details
Age: Up to 6Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: May 22, 2025Locations: 1
Eligibility criteria

Infant less than 6 months of age still on milk diet (total)

Infants with neurological or neurobehavioral disorders [+3]

Status: Recruiting

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.

Participants needed: 4,000
Trial details
Age: Up to 100Biological sex: AllType: ObservationalSponsor: Children's Hospital of Fudan UniversityUpdated: Feb 20, 2025Locations: 1
Eligibility criteria

Postnatal age less than 100 days; [+3]

Reluctance of parents to use genetic sequencing data for subsequent research; [+7]

Status: Not yet recruiting

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.

Participants needed: 36
Trial details
Age: 1-28Biological sex: AllType: InterventionalSponsor: Sultan BesiktasUpdated: Jun 7, 2024
Eligibility criteria

Gestational age greater than 34 weeks [+8]

Rh and ABO incompatibility, [+8]

Status: Recruiting

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.

Participants needed: 200
Trial details
Age: 0-72Biological sex: AllType: ObservationalSponsor: Hunan Children's HospitalUpdated: Apr 16, 2024Locations: 1
Eligibility criteria

The gestational age was 37+0-41+6 weeks and the age was less than 28 days

There was no blood transfusion, no operation, no congenital malformation, no inh...