Premature Infants

9

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

Condition / disease
Location
Status: Not yet recruiting

The Impact of Masseter Muscle Thickness on the Feeding Process in Preterm Infants in Ultrasound Assessment

The aim of this study is to assess masseter muscle thickness using ultrasounds during oral feeding process in premature infants with gestational age from 28+0/7 to 32+0/7 weeks, taking into account the qualitative and quantitative aspects of oral feeding. The main question it aims to answer is: Does the thickness of the masseter muscle influence the course of development of the feeding function in premature newborns? The study will assess the influence of masseter muscle thickness on the oral feeding process in premature infants, which has significant cognitive value due to the dynamic development of feeding function in this group of newborns. Transitioning from enteral feeding via a nasogastric tube to full oral feeding is a crucial stage in the development of one of the most fundamental life functions - nutrition. Complete, effective, and safe oral feeding is also a factor in determining a newborn's discharge from the hospital. Research in the area of feeding is an important and ongoing goal for improving neonatal care in neonatal units. Furthermore, this study will provide preliminary data on masseter muscle thickness in premature infants, which may serve as a basis for further research.

Participants needed: 30
Trial details
Age: 28-32Biological sex: AllType: ObservationalSponsor: Polish Mother Memorial Hospital Research InstituteUpdated: Jun 18, 2026Duration: 4 Months
Eligibility criteria

28+0/7-32+0/7 weeks of gestational age; [+3]

newborns with defects that may significantly affect the development of feeding f... [+8]

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: Not yet recruiting

PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension

The goal of this clinical trial is to evaluate the safety and potential efficacy of PNEUMOSTEM® for improving respiratory outcomes in very premature infants diagnosed with Early Pulmonary Arterial Hypertension. The main questions it aims to answer are: * In very premature infants diagnosed with early pulmonary arterial hypertension, will a single intratracheal administration of PNEUMOSTEM®(Allogeneic umbilical cord blood-derived mesenchymal stem cells) result in improvement of pulmonary arterial hypertension based on echocardiographic assessment? * In very premature infants diagnosed with early pulmonary arterial hypertension who show improvement of pulmonary arterial hypertension based on echocardiographic assessment following a single intratracheal administration of PNEUMOSTEM®(Allogeneic umbilical cord blood-derived mesenchymal stem cells), at what time point does this improvement occur? Participants will: * Single intratracheal dose of PNEUMOSTEM® at 2.0 x 10,000,000 cells/kg * Acute adverse event monitoring: 24 hours post-administration for safety assessment * Follow- up time points: Day 1(Baseline, PNEUMOSTEM® administration), Day 2, Week 1, Week 2, Postnatal Day 28, PMA 36\~40 weeks

Participants needed: 12
Trial details
Phase: Phase 1Age: 1-14Biological sex: AllType: InterventionalSponsor: Samsung Medical CenterUpdated: Jan 26, 2026Locations: 1
Eligibility criteria

Premature infants within 2 weeks of birth with a gestational age of 28 weeks or... [+3]

Those witth cyanotic congenital heart defects or acyanotic congenital heart defe... [+8]

Status: Not yet recruiting

Therapeutic Touch in Premature Infants

Preterm birth is associated with increased physiological instability, stress responses, and developmental vulnerability due to immature organ systems and prolonged exposure to invasive procedures and environmental stressors in neonatal intensive care units (NICUs). In recent years, non-pharmacological, touch-based interventions have gained attention for their potential to support neurodevelopment, improve comfort, and stabilize physiological parameters in preterm infants. Therapeutic Touch (TT) is a non-invasive, holistic intervention based on the modulation of the human energy field through gentle hand movements, aiming to reduce stress, promote relaxation, and support physiological regulation. Although TT has demonstrated beneficial effects in various populations, evidence regarding its effects on preterm infants remains limited. This randomized controlled study aims to evaluate the effects of Therapeutic Touch on behavioral responses, comfort levels, and physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature) in preterm infants hospitalized in the NICU. The findings are expected to contribute evidence for safe, supportive, and holistic neonatal care practices.

Participants needed: 62
Trial details
Age: 28-37Biological sex: AllType: InterventionalSponsor: Selcuk UniversityUpdated: Jan 23, 2026Locations: 1
Eligibility criteria

Infants with a gestational age between 28-37 weeks, [+4]

Infants with:heart disease, [+7]

Status: Recruiting

The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants

This randomized controlled trial investigates the effects of massage therapy on sleep quality, stress, comfort, and vital signs in preterm infants (gestational age 35-37 weeks) admitted to the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. Infants in the intervention group will receive a 15-minute massage three times a day for three consecutive days, while the control group will receive standard care. Data will be collected using the Premature Infant Comfort Scale, Neonatal Stress Scale, actigraphy for sleep monitoring, and vital sign measurements. The study aims to determine whether massage therapy can improve the overall well-being and development of preterm infants in NICU settings.

Participants needed: 40
Trial details
Age: 35-37Biological sex: AllType: InterventionalSponsor: Yuzuncu Yil UniversityUpdated: Jan 7, 2026Locations: 1
Eligibility criteria

Preterm infants born between 35-37 weeks gestational age. [+3]

Infants with congenital anomalies or major medical complications. [+3]

Status: Recruiting

Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants

A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.

Participants needed: 24
Trial details
Phase: Phase 2Age: 24-29Biological sex: AllType: InterventionalSponsor: Monash Medical CentreUpdated: Nov 28, 2025Locations: 2
Eligibility criteria

Born between 24+0 and 28+6 weeks of gestation

Inability of the legal representatives to consent, [+8]

Status: Recruiting

Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)

This study is designed to answer one of the fundamental gaps in knowledge in the resuscitation of preterm infants at birth: What is the optimal target oxygen saturation (SpO2) range that increases survival without long-term morbidities? Oxygen (O2) is routinely used for the stabilization of preterm infants in the delivery room (DR), but its use is linked with mortality and several morbidities including bronchopulmonary dysplasia (BPD). To balance the need to give sufficient O2 to correct hypoxia and avoid excess O2, the neonatal resuscitation program (NRP) recommends initiating preterm resuscitation with low (≤ 30%) inspired O2 concentration (FiO2) and subsequent titration to achieve a specified target SpO2 range. These SpO2 targets are based on approximated 50th percentile SpO2 (Sat50) observed in healthy term infants. However, the optimal SpO2 targets remain undefined in the preterm infants. Recent data suggest that the current SpO2 targets (Sat50) may be too low. The investigators plan to conduct a multicenter RCT of Sat75 versus Sat50 powered for survival without BPD. The investigators will randomize 700 infants, 23 0/7- 30 6/7 weeks' GA, to 75th percentile SpO2 goals (Sat75, Intervention) or 50th percentile SpO2 goals (Sat50, control). Except for the SpO2 targets, all resuscitations will follow NRP guidelines including an initial FiO2 of 0.3. In Aim 1, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without lung disease (BPD). In addition, the investigators will compare the rates of other major morbidities such as IVH. In Aim 2, the investigators will determine whether targeting Sat75 compared to Sat50 increases survival without neurodevelopmental impairment at 2 years of age. In Aim 3, the investigators will determine whether targeting Sat75 compared to Sat50 decreases oxidative stress.

Participants needed: 700
Trial details
Age: 0-10Biological sex: AllType: InterventionalSponsor: University of Texas Southwestern Medical CenterUpdated: Aug 5, 2025Locations: 1
Eligibility criteria

Prenatally diagnosed cyanotic congenital heart disease [+3]

Status: Recruiting

Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment

Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords. Crying is usually caused by pain, discomfort, hunger, or separation from parents or other caregivers. Crying carries essential information from birth, the expression of which depends closely on the neuroanatomical and functional brain integrity of the child. On a bioacoustic level, crying consists of sequences of complex acoustic signals produced by the vocal folds and filtered by the vocal tract. The vibration frequency of the vocal cords determines the cry's fundamental frequency f0 (and the harmonic frequencies), which is responsible for its more or less low or high pitch. Other acoustic cues also characterize each baby's cry.

Participants needed: 1,100
Trial details
Age: Up to 4Biological sex: AllType: ObservationalSponsor: Centre Hospitalier Universitaire de Saint EtienneUpdated: May 28, 2025Locations: 1
Eligibility criteria

For a full-term baby > 37 weeks [+5]

Refusal of participation by the holder of parental authority [+4]

Status: Recruiting

Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)

Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates

Participants needed: 100
Trial details
Age: 26-32Biological sex: AllType: InterventionalSponsor: CHRISTUS HealthUpdated: Aug 15, 2024Locations: 1
Eligibility criteria

Children (Minor < 18 years of age) [+4]