Infant, Premature

12

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

Condition / disease
Location
Status: Not yet recruiting

Fentanyl and Rocuronium for Tracheal Intubation in Newborns

Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen desaturation, bradycardia, and airway trauma - are frequent. Premedication with neuromuscular blocking agents has been associated with improved intubation conditions and fewer adverse events in neonates. This randomized, double-blind, parallel-group clinical trial (NEORIN) aims to evaluate whether the addition of rocuronium (0,6 mg/kg IV) to standard fentanyl premedication (1 mcg/kg IV) improves first-attempt success rates of tracheal intubation in newborns admitted to the NICU of Maternidade Ana Braga, Manaus, Brazil. The control group will receive fentanyl plus saline placebo. Sugammadex (16 mg/kg IV) is available as a reversal agent in case of prolonged neuromuscular blockade. A secondary aim is to assess neonatologists' and residents' knowledge of and barriers to the use of neuromuscular blocking agents in neonatal intubation.

Participants needed: 102
Trial details
Phase: Phase 4Age: 1-28Biological sex: AllType: InterventionalSponsor: UEA - Universidade Do Estado Do AmazonasUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Newborns admitted to the NICU, ≤28 postnatal days OR corrected gestational age <... [+2]

Upper airway malformations [+7]

Status: Recruiting

Follow-up Visit of High Risk Infants

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.

Participants needed: 68,000
Trial details
Age: 18-26Biological sex: AllType: ObservationalSponsor: NICHD Neonatal Research NetworkUpdated: Jul 1, 2026Locations: 31
Eligibility criteria

Infants inborn at NRN centers [+2]

Status: Not yet recruiting

Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants

The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm infants. ROP is an eye condition that can affect babies born too early and requires regular eye examinations. The main questions this study aims to answer are: Does intranasal fentanyl lower pain during ROP screening? Is intranasal fentanyl safe for preterm infants? Researchers will compare intranasal fentanyl with a placebo (a saltwater spray that contains no medicine) to determine whether the medicine lowers pain during ROP screening. Participants will receive either intranasal fentanyl or placebo before their routine ROP eye examination, in addition to the standard comfort measures normally used during the procedure. Researchers will measure participants' pain and monitor their heart rate, oxygen levels, and any side effects during and after the examination.

Participants needed: 58
Trial details
Phase: Phase 1, Phase 2Biological sex: AllType: InterventionalSponsor: Marsha Campbell-YeoUpdated: Jun 30, 2026Locations: 1
Eligibility criteria

Preterm infants born ≤31 weeks gestational age and/or with birth weight <1250 g [+3]

Congenital anomalies or conditions affecting the nasal passages that would inter... [+2]

Status: Not yet recruiting

Bed Rest With a Short Cervix on Preterm Birth

Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily. The use of maternal AR to prevent preterm birth is largely based on observational evidence linking strenuous physical activity to an increased risk of preterm birth, and the assumption that reduced activity may decrease myometrial activity. However, the existing evidence on the clinical effects of AR remains limited and has not demonstrated a reduction in preterm birth or a delay in deliv-ery. In contrast, some studies suggest a potential increase in preterm birth following AR and instead significant adverse maternal and fetal effects. The overall aim of this study is to compare gestational age at birth in women with a short cervix who are prescribed AR compared with women with a short cervix who are not prescribed AR (NAR). The primary hypothesis is that NAR is non-inferior to AR in prolonging pregnancy in women with a short cervix. Secondary hypotheses are that, compared with AR, NAR is associated with higher level of physical activity, lower risk of maternal depression, and reduced risk of loss of maternal bone mineral density. Through the BEWISE study, we wish to implement a change in the Danish national clinical practice regarding AR from recommending AR in risk groups (current practice) to no longer recommending AR as part as routine care (new practice). We will evaluate this change in clinical practice by prospectively collecting data from women both before and after implementation of the new recommendation. The transition from AR to NAR will be implemented sequentially in each Danish region using a randomised stepped-wedge (SW) cluster design, with each region constituting a cluster. The order in which regions transition is determined by randomisation. Each region will adopt the new recommendation at 3-month intervals, resulting in full national transition from AR to NAR within 12 months Eligible participants are pregnant women in gestational age 20+0 to 33+6 and cervical length \< 25 mm in singleton pregnancies and \< 30 mm in multiple pregnancies. Participants must be above 18 years of age and be able to read and understand Danish or English. There are no exclusion criteria. The primary outcome is gestational age in days (continuous).

Participants needed: 6,000
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Julie GlavindUpdated: May 11, 2026
Eligibility criteria

Cervical length < 25 mm in singleton pregnancies and < 30 mm in multiple pregnan... [+2]

Status: Recruiting

Generic Database of Very Low Birth Weight Infants

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

Participants needed: 80,000
Trial details
Age: Up to 14Biological sex: AllType: ObservationalSponsor: NICHD Neonatal Research NetworkUpdated: Mar 16, 2026Locations: 31
Eligibility criteria

401-1000 grams birth weight, and/or [+2]

Infants >1,000 grams birth weight and/or >29 weeks gestational age

Status: Recruiting

Personalized Music Therapy for Preterm Infants

Preterm infants in the Neonatal Intensive Care Unit (NICU) face environmental and clinical stressors that may affect physiological stability and development. This pilot randomized crossover study tests Personalized Music Therapy (PMT) based on recorded parental voices versus Quiet Rest. Outcomes include tissue oxygenation index (TOI) via near-infrared spectroscopy (NIRS) and heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2). Each infant completes two Periods (PMT and Quiet Rest) in randomized order, separated by a 2-day washout. Parental stress is measured at discharge using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU). Findings inform feasibility, variance estimates, and protocol refinements for a larger trial.

Participants needed: 20
Trial details
Age: 5-15Biological sex: AllType: InterventionalSponsor: Fabrizio FainaUpdated: Dec 19, 2025Locations: 1
Eligibility criteria

Preterm infants admitted to the Neonatal Intensive Care Unit (NICU) of Azienda O... [+6]

Post-operative status at the time of enrollment. [+5]

Status: Not yet recruiting

Dexamethasone Regimens for BPD Prevention in Preterm Infants

The goal of this clinical trial is to compare the effectiveness of two different dexamethasone treatment regimens (the DART regimen and the medium-dose tapering regimen) in reducing the incidence of Bronchopulmonary Dysplasia (BPD) or death by 36 weeks of postmenstrual age in premature infants. This study will also assess the safety of these treatments. The main questions it aims to answer are: Does the DART regimen, compared to the medium-dose tapering regimen, lower the rate of BPD or BPD-related death by 36 weeks of postmenstrual age in eligible premature infants? How do the two regimens compare in terms of short-term respiratory outcomes (like time to come off the ventilator), complications at hospital discharge, and long-term neurodevelopmental outcomes at 18-24 months of corrected age? Researchers will compare the DART regimen group (lower cumulative dose, given over 10 days) to the medium-dose tapering regimen group (higher cumulative dose, given over 7 days) to see which one is more effective and safer. Participants will: Inclusion Criteria (Must meet ALL of the following) 1. Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone. 2. FiO₂ \> 40% and MAP \> 8 cmH₂O (maintained for at least 24 hours prior to enrollment). 3. Parent/Legal guardian has provided signed informed consent. 4. No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria. 2\. Exclusion Criteria (Will be excluded if they meet ANY of the following) 1. Presence of ventilator-associated pneumonia at the time of enrollment. 2. Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency. 3. Suffering from other severe life-threatening illnesses with a short-expected survival time. 4. Parent/Legal guardian refuses to participate in the study.

Participants needed: 970
Trial details
Phase: Phase 3Age: 14-28Biological sex: AllType: InterventionalSponsor: The Children's Hospital of Zhejiang University School of MedicineUpdated: Nov 24, 2025Locations: 24
Eligibility criteria

Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for... [+3]

Presence of ventilator-associated pneumonia at the time of enrollment. [+3]

Status: Recruiting

Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants

This randomized controlled study aims to evaluate the effects of kangaroo care combined with maternal voice and fetal positioning on the comfort, growth, and transition to full oral feeding in preterm infants aged 30 to 34 weeks gestation. After ethical approval, eligible infants in the neonatal clinic will be randomly assigned to either the intervention group receiving kangaroo care, maternal voice, and fetal positioning, or a control group receiving only fetal positioning in the incubator. The intervention involves daily one-hour kangaroo care sessions with maternal storytelling, followed by positioning in the lateral fetal posture, continuing at least five days per week until infants achieve full oral feeding. Infant comfort will be assessed regularly using the Neonatal Comfort Behavior Scale before feeding, immediately after kangaroo care, and after fetal positioning. Growth parameters, including weight, length, and head circumference, will be measured and recorded on kangaroo care days. The control group will receive routine fetal positioning without kangaroo care, with identical measurements taken. The study aims to determine whether kangaroo care combined with maternal voice and fetal positioning improves infant comfort, supports growth, and facilitates the transition to full oral feeding in preterm newborns.

Participants needed: 68
Trial details
Age: 30-34Biological sex: AllType: InterventionalSponsor: Fenerbahce UniversityUpdated: Sep 4, 2025Locations: 1
Eligibility criteria

Infants with a gestational age between 30-34 weeks. [+5]

Presence of a congenital anomaly or genetic disease. [+6]

Status: Not yet recruiting

Heterogeneity Index in Neonatologist-performed Lung Ultrasound in Neonates Receiving Respiratory Support - a Pilot Study

Lung ultrasound is an increasingly valuable diagnostic tool in neonatal intensive care due to its safety and accessability. This pilot study investigates whether a quantitative approach - the heterogeneity index, previously only used in fetal lung assessment - can enhance the diagnostic accuracy of neonatologist-performed lung ultrasound (NPLUS). The index will be calculated from raw ultrasound images of preterm and term neonates and compared with conventional lung ultrasound scores to evaluate its clinical relevance.

Participants needed: 40
Trial details
Age: 1-7Biological sex: AllType: ObservationalSponsor: Medical University of GrazUpdated: Aug 12, 2025Locations: 2
Eligibility criteria

Preterm neonates born between 28+0 and 36+6 weeks of gestation and term-born neo... [+2]

cardiopulmonary malformations [+2]

Status: Not yet recruiting

Global Survey on Newborns' HOspitalisation and Parental Experiences - the HOPE Study

This study aims to explore parents' experiences and emotional burdens related to their newborn's hospital stay using an online survey. Our target population consists of parents of newborns born preterm, with low birthweight, or critically ill. Particularly the presence of infant- and family-centred developmental care (IFCDC) principles as well as support through political framework conditions will be investigated.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Global Foundation for the Care of Newborn InfantsUpdated: Apr 27, 2025Locations: 1
Eligibility criteria

Other family members than parents/(primary) caregivers [+3]

Status: Recruiting

Extremely Preterm Respiratory Outcome Cohort

This study examines the respiratory outcomes of preterm infants born at gestational ages less than 29 weeks, spanning from birth to 24 months corrected age. It delves into the intricacies of respiratory function impairment attributable to diverse factors, such as respiratory distress syndrome, bronchopulmonary dysplasia, postnatal corticosteroids, ventilatory support, as well as nutritional aspect during NICU stay. Furthermore, it scrutinizes the incidence of chronic respiratory diseases stemming from these conditions, assessing their long-term impact on respiratory prognosis post-discharge. In addition to respiratory aspects, the research extends its focus to the growth and developmental outcomes of preterm infants. By synthesizing these multifaceted elements, the study aspires to enhance current treatments and preventative measures for respiratory conditions in preterm infants.

Participants needed: 600
Trial details
Age: Up to 7Biological sex: AllType: ObservationalSponsor: Seoul National University HospitalUpdated: Dec 10, 2024Locations: 1Duration: 6 Years
Eligibility criteria

Infants born at gestational age less than 29 weeks with cohort consent obtained...

death within 3 days of birth [+4]

Status: Not yet recruiting

Effects of an Information-Based Discharge Service on Preterm Infants, Parents, and Hospitals

Background:The Information-Based Discharge Preparation Service (IBDPS) supports parents of preterm infants during the transition from hospital to home, but its effectiveness has not been widely studied. Objective:To evaluate the impact of IBDPS on parental readiness, caregiving skills, stress, satisfaction, infant development, readmission rates, length of stay, and hospital costs. Design: A randomized controlled trial (RCT) in a NICU in Jiangsu Province, China. Participants: Preterm infants and their parents. Methods:Participants are randomly assigned to receive either IBDPS plus usual care (intervention group) or usual care alone (control group). Data on parental and infant outcomes are collected at various stages from admission to one month post-discharge, along with hospital metrics like length of stay and readmission rates.

Participants needed: 86
Trial details
Age: Up to 37Biological sex: AllType: InterventionalSponsor: The First Affiliated Hospital with Nanjing Medical UniversityUpdated: Sep 26, 2024
Eligibility criteria

Infants with a gestational age of less than 37 weeks at birth. [+2]

Presence of major life-threatening congenital anomalies. [+11]