Preterm Infant

10

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

Condition / disease
Location
Status: Recruiting

Habituation's Mechanisms in Preterm and Term Infants

Each year in France, 7 % of newborns are born preterm (before 37 weeks of gestational age (GA)). The investigators called very preterm infants those who were born before 33 weeks of GA. These very preterm infants have a higher risk of developing neurological complications like developmental disabilities or cerebral palsy. To date, early assessment of these infants is difficult and not reliable enough to detect those who are at risks of developing neurological issues. Now, the investigators need to identify earlier these infants to provide them interventions to improve their development (physical therapy for example). Consequently, the investigators are examining a study whose aim is to assess preterm infants habituation. Habituation is the newborn ability to become familiar with new environmental stimulations (noise, light…). This habituation allows the newborn to maintain his sleep even at onset of a noise or light. To study this phenomenon in infants born preterm near to corrected term (around 40 weeks of postnatal GA), will allow us to better understand neurological development of these infants. The investigators plan to compare habituation skills of preterm infants near to their theorical date of birth (40 weeks of GA) to a population of infants born at term. The investigators will also study the link between habituation abilities and sleep quality as well as neurodevelopmental outcome at the corrected age of two years old.

Participants needed: 70
Trial details
Age: 2-10Biological sex: AllType: ObservationalSponsor: University Hospital, BrestUpdated: Jun 12, 2026Locations: 1
Eligibility criteria

Preterm infants: preterm infants born from 25 weeks to 32 weeks + 6 days of gest... [+2]

no malformation or chromosomal abnormality, life threatening disease, administra...

Status: Not yet recruiting

Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial

This clinical trial aims to find out whether a circadian-synchronized breast milk feeding approach can help improve sleep in preterm infants in the neonatal intensive care unit (NICU). The study mainly aims to answer the following questions: Can this feeding approach improve sleep in preterm infants? Can this feeding approach help preterm infants develop more regular sleep patterns compared with routine breast milk feeding? Researchers will compare a feeding approach that tries to match the time when breast milk was expressed with the time when the baby is fed, with routine breast milk feeding, to see whether this method can improve sleep in preterm infants. Participants will: Be randomly assigned to 1 of 2 groups: circadian-synchronized breast milk feeding or routine breast milk feeding. Receive the assigned feeding approach for at least 2 weeks during the study. Have one 12-hour continuous sleep monitoring session at 37 weeks of corrected age. Have changes in different sleep states recorded and analyzed during the study, so that sleep patterns can be compared between the 2 groups.

Participants needed: 120
Trial details
Age: 0+Biological sex: AllType: InterventionalSponsor: Shanghai Jiao Tong University School of MedicineUpdated: Jun 12, 2026Locations: 6
Eligibility criteria

Not listed

Status: Not yet recruiting

Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants

Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems. These respiratory events include pauses in breathing, shallows breaths, and irregular breathing patterns. These problems are most common right after birth but can continue for weeks, leading to extended hospital stays, higher medical costs, and potential long-term health concerns affecting the eyes, lungs, and brain. Currently, neonatal intensive care units (NICUs) use methods like measuring oxygen levels, heart rate, and electrical resistance in the chest to monitor for respiratory events. However, these methods have limitations. For instance, they cannot accurately measure airflow and do not distinguish between different types of respiratory events. As a results, some breathing problems might go unnoticed or be managed improperly. To address this, the investigators have developed a wireless acoustic sensor that uses advanced microphones and motion sensors to record airflow and chest movements. In initial tests with healthy preterm infants, this sensor proved reliable in detecting breathing patterns and airway obstruction, suggesting it could offer a more precise and non-invasive monitoring method. This study aims to assess how well this new sensor performs compared to existing methods in detecting and distinguishing different types of respiratory events in a high-risk group of extremely preterm infants. The investigators will track respiratory patterns in preterm infants at various stages between 32 and 44 weeks of age. By comparing the new sensor's performance with currents standards and gold-standard methods, the investigators hope to improve the management of these respiratory events and reduce the related health risks.

Participants needed: 50
Trial details
Age: Up to 29Biological sex: AllType: ObservationalSponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreUpdated: May 12, 2026Locations: 1Duration: 9 Weeks
Eligibility criteria

Infants with gestational age < 29+0 weeks. [+1]

Infants with known major congenital anomalies. [+1]

Status: Not yet recruiting

Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants

A clinical quality improvement bundle on early nutrition supplementation is developed to improving the clinical outcomes (including growth, organ function, and neurodevelopment outcomes) of extremely and/or very preterm infants. This bundle consists of three aspects: individualized and precise human milk feeding, early enteral zinc supplementation, and routine parenteral carnitine supplementation.

Participants needed: 200
Trial details
Age: Up to 1Biological sex: AllType: InterventionalSponsor: Children's Hospital of Fudan UniversityUpdated: Apr 20, 2026Locations: 1
Eligibility criteria

(1) Admitted to the Neonatal Department of Children's Hospital of Fudan Universi... [+3]

(1) Newborns with severe congenital diseases, severe congenital malformations, c... [+6]

Status: Recruiting

Acoustics as a Metric of Airway Pressure in Premature Infants Using Bubble Continuous Positive Airway Pressure

This is an observational, proof-of-concept, feasibility study where 30 preterm infants on bubble CPAP with gestational age \< 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital. The study's main goals are: 1. To determine the relationship between ambient bubbling sounds and delivered pressures in preterm infants on bCPAP. 2. To determine the relationship between transmitted bubbling sounds and airway pressures transmitted to the lungs of preterm infants on bCPAP. 3. To develop models to predict delivered and transmitted bCPAP pressures from the acoustic properties of bubbling sounds.

Participants needed: 30
Trial details
Age: 28-32Biological sex: AllType: ObservationalSponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreUpdated: Mar 30, 2026Locations: 1
Eligibility criteria

Infants on bCPAP with gestational age < 32+0 weeks [+4]

Infants with known major congenital anomalies [+6]

Status: Recruiting

Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.

During intrauterine life, some babies are smaller or grow less than expected. This fetal growth abnormality, called fetal growth restriction (FGR), can be diagnosed by ultrasound. Since there are currently no curative treatments for this condition, nor methods to optimize the growth of babies in the womb, the only effective strategy is intensive monitoring of fetal conditions, accompanied by early planning of delivery. The diagnosis of early FGR (i.e. diagnosed before 32 weeks of gestation) confers a greater risk of short- and long-term respiratory problems. The study aims to examine the association between parameters that can be assessed during pregnancy by ultrasound, such as the estimate of lung volumes, the thickness and contractility of the diaphragm, and cardiac kinetics, and any perinatal complications and respiratory function in the first years of life of premature infants, both with and without evidence of fetal growth pathology. Therefore, the study is divided into two phases: a prenatal and a postnatal phase. The study includes two groups of patients: 1. Study group: Fetuses and preterm infants with a prenatal history of FGR; 2. Control group: Preterm infants without a prenatal history of FGR followed during neonatal follow-up. Pregnant women with fetuses with FGR are followed at the Ultrasound clinics dedicated to Growth Pathology. These pregnancies usually receive weekly ultrasound monitoring, which includes a Doppler study of the maternal and fetal circulation and an estimate of fetal weight every two weeks. Cardiotocographic monitoring is also planned once or twice a week, depending on fetal well-being. The child will be assessed from a respiratory point of view during hospitalization and subsequently in the outpatient clinic, as required by clinical practice. He/she will undergo respiratory function tests. Visits are scheduled at 3, 6, 12 and 24 months of corrected age, during which at least two respiratory function tests will be performed. In addition, routine clinical data (personal data, medical history, blood tests, biological and instrumental tests) present in the medical record of the child will be collected. Data from preterm infants without fetal growth restriction will be collected after informed consent. These infants are routinely followed at our Institution and undergo clinical assessment and lung function tests in the first two years of life as previously indicated.

Participants needed: 54
Trial details
Biological sex: AllType: ObservationalSponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUpdated: Aug 26, 2025Locations: 1Duration: 2 Years
Eligibility criteria

Fetuses and Infants born before 32 weeks of gestation, with and without fetal gr...

Lack of informed consent [+2]

Status: Recruiting

Positive Feeding of the Preterm Infant

The goal of this feasibility study is to assess the feasibility to implement a feeding strategy for preterm infants. The main questions it aims to answer are: * Is it feasible to implement the PoP-intervention in a level 3a category Neonatal intensive care unit? * Is the PoP-intervention acceptable for parents of preterm infants and health care personnel working in Neonatal intensive care unit? Parents of preterm infants and health care personnel will be asked to follow a protocol of a feeding strategy based on the preterm infants development and cues throughout the NICU-stay.

Participants needed: 15
Trial details
Biological sex: AllType: InterventionalSponsor: Oslo Metropolitan UniversityUpdated: Aug 11, 2025Locations: 1
Eligibility criteria

gestational age of 28 weeks [+1]

diagnoses or malformations that makes eating difficult [+3]

Status: Recruiting

Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants

This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.

Participants needed: 80
Trial details
Age: 1-48Biological sex: AllType: ObservationalSponsor: Korea University Anam HospitalUpdated: Jun 17, 2025Locations: 2Duration: 2 Years
Eligibility criteria

Preterm infants born between 27 weeks 0 days to 31 weeks 6 days of gestation [+1]

Preterm infants who die within the first 48 hours of life [+3]

Status: Recruiting

Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity

Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment. The investigator research hypothesis is that a new calculation of the air temperature in the incubator would promote the newborn infant weight growth from the period between birth and day 10 of life compared to cutaneous mode. The secondary hypotheses assumes a decrease in the side effects usually observed in both morbidity and mortality. A software is used to calculate the body heat loss (BHL) of each individual preterm infant, and to propose a specific air temperature setting inside the incubator to reduce BHL to zero. This software has been validated in a previous pilot study (Degorre et al. 2015). This study aims to compare the energy costs of providing incubated preterm infants born between 25 and 32 weeks of gestation with homeothermia using either specific individualized air temperature control (ATC) or skin servocontrol (SSC).

Participants needed: 164
Trial details
Age: Up to 1Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: May 29, 2025Locations: 1
Eligibility criteria

preterm infant born between 25+0 and 32+0 weeks of gestation [+3]

newborn infant with polymalformative syndrome [+1]

Status: Recruiting

Gut Microbiota of Preterm Infants and Full-term Infants at Early Life

The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome. The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.

Participants needed: 102
Trial details
Age: 1-4Biological sex: AllType: ObservationalSponsor: Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUpdated: Apr 17, 2024Locations: 1
Eligibility criteria

gestational age <37 weeks; [+2]

NICU stay less than 7 days [+5]