Infant, Premature, Diseases

8

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

Condition / disease
Location
Status: Recruiting

PK/PD of Digoxin in Infants With SVHD

The primary participant will be an infant with single ventricle heart disease. This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in pediatric cardiac intensive care units is processed by their bodies and how it may help their cardiac function. The investigators will collect blood or will collect blood samples when bloodwork is checked as part of regular care ("opportunistic"). The investigators will also collect information from medical records. Being part of this study will not change treatment plan or medications. The risks of this study include loss of confidentiality and risks associated with having blood drawn. The study team will make every effort to minimize these risks.

Participants needed: 20
Trial details
Phase: Phase 1, Phase 2Age: 30-6Biological sex: AllType: InterventionalSponsor: Duke UniversityUpdated: Jan 30, 2026Locations: 2
Eligibility criteria

Diagnosis of single ventricle congenital heart disease [+5]

Gestational age at birth <35 weeks [+7]

Status: Recruiting

Forced Oscillometry in Infants With Bronchopulmonary Dysplasia

The purpose of this study is to use forced oscillometry technique (FOT) to measure pulmonary mechanics and function in in term infants and premature infants with bronchopulmonary dysplasia (BPD)

Participants needed: 80
Trial details
Biological sex: AllType: ObservationalSponsor: Winston ManimtimUpdated: Jan 21, 2026Locations: 1
Eligibility criteria

Premature infants with BPD who are in room air based on the (per NICHD definitio... [+6]

Infants with BPD requiring invasive or non-invasive positive pressure ventilatio... [+1]

Status: Recruiting

Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants

The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants). The main question that this clinical trial aims to answer is: Does M-MILK improve stress regulation, support optimal neurodevelopment, and promote competent oral feeding skills in very preterm infants? Researchers will compare M-MILK to the standard of care to see if M-MILK helps very preterm infants. Specifically, researchers will compare the differences in: * Cortisol levels * DNA methylation of the two stress related genes (NR3C1 and HSD11B2) * Neurodevelopment * Oral feeding skills Participants in the M-MILK group will receive standard of care plus M-MILK intervention, which starts on day 3 of life and continues until they begin their oral feeding. M-MILK will be provided by clinical research nurses, during the day shift, up to 4 times a day. Participants in the standard of care group will continue to receive their usual care.

Participants needed: 125
Trial details
Age: 23-32Biological sex: AllType: InterventionalSponsor: Loyola UniversityUpdated: Jan 20, 2026Locations: 2
Eligibility criteria

Born at ≤ 32 weeks gestational age. [+1]

Receiving only formula. [+4]

Status: Recruiting

Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.

Participants needed: 188
Trial details
Age: 1-17Biological sex: AllType: InterventionalSponsor: University of Alabama at BirminghamUpdated: Dec 29, 2025Locations: 1
Eligibility criteria

inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off...

a major malformation, a known syndrome, enrolled in a competing trial targeting...

Status: Recruiting

Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants

Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during transitional circulation (first 72 hours from birth).

Participants needed: 30
Trial details
Phase: Phase 1, Phase 2Age: Up to 72Biological sex: AllType: InterventionalSponsor: Instituto de Investigación Hospital Universitario La PazUpdated: Mar 17, 2025Locations: 3
Eligibility criteria

Born with up to 32(+6) weeks gestation [+2]

Neonates considered non-viable, with a clinical decision not to provide life sup... [+5]

Status: Recruiting

The NEU-STIM Trial

The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.

Participants needed: 3,280
Trial details
Age: Up to 32Biological sex: AllType: InterventionalSponsor: Leiden University Medical CenterUpdated: Mar 10, 2025Locations: 43
Eligibility criteria

Infants born before 32 weeks of gestation can be included in this trial after pa...

Infants will be excluded if they are found to have a congenital abnormality or c...

Status: Recruiting

Optimising Ventilation in Preterms With Closed-loop Oxygen Control

Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. The use of supplemental oxygen may also increase the risk of comorbidities such as retinopathy of prematurity. Therefore, oxygen saturation levels and the amount of inspired oxygen concentration provided should be continuously monitored. Oxygen control can be performed manually or with the use of a computer software incorporated into the ventilator that is called 'closed loop automated oxygen control'(CLAC). The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range but there are no data to determine the effect on important clinical outcomes. A previous study has also demonstrated that CLAC reduces the inspired oxygen concentration more rapidly when compared to manual control. That could help infants come off the ventilator sooner. With this study we want to compare the time preterm infants spend on the ventilator when we use the software to automatically monitor their oxygen levels with those infants whose oxygen is adjusted manually by the clinical team. That could help us understand if the use of automated oxygen control reduces the duration of mechanical ventilation and subsequently the complications related to it.

Participants needed: 70
Trial details
Biological sex: AllType: InterventionalSponsor: King's College Hospital NHS TrustUpdated: Oct 23, 2024Locations: 1
Eligibility criteria

Preterm infants less than 31 weeks completed gestation at birth requiring mechan...

Preterm infants above 31 weeks completed gestation or term born infants [+1]

Status: Not yet recruiting

Maternal & Infant Morbidity and Mortality

The purpose of this project is to evaluate maternal and infant outcomes based on race at UVA hospital. Health inequities are influenced by a combination of Social, Political, and Clinical determinants of health. Our hypothesis is that patients with minority status, particularly Black and Hispanic Americans, are more likely to have poor outcomes (based on various health metrics) compared to Non-Black, Non-Hispanic patients. We hypothesize further that it is likely not far off from national trends, which indicate that Black parturients are x4 more likely to die during childbirth, and Black children are 2.4x more likely to die before their first birthday than Non-Hispanic White children. The EPIC database will be used on an institutional basis to obtain information and accessed by UVA statistician to perform the research described in this submission. The dataset does contain a few direct identifiers of medical record numbers, dates, and postal number. We anticipate that all statistical analysis will be performed at UVA by participating faculty/staff.

Participants needed: 1,000
Trial details
Biological sex: FemaleType: ObservationalSponsor: University of VirginiaUpdated: Nov 24, 2023
Eligibility criteria

pregnant women

N/A