PreTerm Neonate

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

Condition / disease
Location
Status: Recruiting

PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY

Babies born early (under 32 weeks) are at risk of developing lung problems after birth. A major reason for this is that the lungs are not fully developed. Lungs of preterm babies will often collapse in between breathing due to lung immaturity. Applying gentle pressure, using nasal device through their nostril or through the breathing tube helps to prevent this lung collapse. This would help in air-oxygen going to lungs and also makes the babies breathing more comfortable. This gentle pressure is medically called as PEEP/CPAP and could be delivered by breathing machine (ventilator) and CPAP machine, collectively called as "continuous distending pressure (CDP)". Those babies breathing on their own and receiving inadequate CDP would need more breathing support by placing them on breathing machine (ventilator). The longer the baby receives breathing machine support, higher chance of lung injury . Preterm infants who are already on breathing machine, providing sub optimal PEEP/CPAP could also lead to lung damage. Providing optimal PEEP/CPAP could prevent these negative outcomes. Currently there is not enough evidence to suggest optimal PEEP/CPAP in preterm infants. Neonatal units all around the world uses PEEP/CPAP ranging from 4 to 10cm H20 based on their unit practice. Currently available investigations provide limited one time information (e.g. Chest X-ray) regarding whether baby is receiving optimal PEEP/CPAP. Electrical Impedance Tomography (EIT) is a new technology which could provide better information regarding the pressure delivered. Also, this device would provide continuous information as if the clinicians are doing continuous chest X-ray but without any radiation. In this study, the team will assess the effect of different levels of PEEP/CPAP (4 to 10cm H20) on prevention of lung collapse using EIT. This would be studied in premature infants who are on breathing machine support and CPAP machine support.

Participants needed: 30
Trial details
Age: 22-32Biological sex: AllType: InterventionalSponsor: South Tees Hospitals NHS Foundation TrustUpdated: May 6, 2026Locations: 1
Eligibility criteria

Gestational age <32 weeks based on mother's last menstrual period or first trime... [+3]

Major congenital malformations including congenital lung disease and congenital... [+3]

Status: Recruiting

Breathing Patterns in Infants Before and After Extubation

The primary objective of this study is to compare work of breathing indices before and after extubation in intubated premature infants admitted to the Christiana Care Neonatal Intensive Care Unit. The secondary objective is to compare the ability of work of breathing indices to predict extubation failure to routine spontaneous breathing tests (SBTs) in intubated premature infants admitted to the ChristianaCare NICU.

Participants needed: 30
Trial details
Age: 0-6Biological sex: AllType: ObservationalSponsor: Christiana Care Health ServicesUpdated: Apr 21, 2026Locations: 1
Eligibility criteria

premature infants (born at ≤32 weeks gestation) who are intubated. [+1]

Infants with skeletal, neuromuscular, or abdominal surgical disorders that affec...

Status: Recruiting

MINImising Total Radiation EXposure in Preterm Infants

Being born too early (preterm birth) is the leading cause of death in children world-wide. In Australia, 97% of very preterm babies who are admitted to Neonatal Intensive Care Units need breathing support after birth to survive. Despite this significant global impact, neonatal clinicians have few tools available to guide breathing support. Currently, the only lung imaging tool that is routinely used in the Neonatal Intensive Care Unit is a chest X-ray. To reduce radiation exposure, chest X-rays are usually only performed one or two times a day. As chronic lung disease in babies who survive preterm birth is increasing, there is an urgent need to develop new ways to monitor the lungs of these fragile babies. Lung ultrasound is a form of imaging that is fast, gentle and radiation free. However, it has not been routinely adopted into caring for preterm babies in most countries. This is because there are no randomised controlled trials that have demonstrated the benefit and safety of using lung ultrasound as the first-line imaging tool in preterm babies. The investigators will conduct a randomised controlled trial to demonstrate that lung ultrasound is a quick, safe and accurate alternative to chest x-rays in preterm babies.

Participants needed: 180
Trial details
Phase: Phase 2Age: Up to 24Biological sex: AllType: InterventionalSponsor: Western Health, AustraliaUpdated: Apr 16, 2026Locations: 1
Eligibility criteria

The infant is born from 22 to 31+6 weeks' gestation by best obstetric estimate a... [+2]

The infant will only require CXR to be performed solely to confirm device positi... [+5]

Status: Recruiting

Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.

The purpose of this observational study is to learn about neonatologists' perceptions of extubation readiness and extubation and reintubation practices in extremely preterm infants in the first 2 weeks of life using prospective qualitative and quantitative data. Actual extubation readiness is defined as successful extubation, defined as no reintubation in the 7 days following extubation. Key research questions are: How do clinicians assess extubation readiness in this population? Does this assessment correlate with actual extubation success? What factors (reasons, clinical status, ventilatory parameters) are associated with extubation readiness? Patients born before 28 weeks gestational age and admitted to the neonatal intensive care unit (NICU) within the first 24 hours are be included. The attending physician will complete a prospectively administered questionnaire with open-ended and multiple-choice questions to daily assess the decision and rationale for extubation or non-extubation of patients mechanically ventilated during the first 15 days of life. Patient characteristics, respiratory outcomes, and mortality will be recorded until the end of hospitalisation and/or definitive weaning from any ventilatory support or supplemental oxygen.

Participants needed: 100
Trial details
Age: 1-5Biological sex: AllType: ObservationalSponsor: Centre Hospitalier Intercommunal CreteilUpdated: Mar 12, 2026Locations: 31
Eligibility criteria

Gestational age < 28 weeks of gestation [+1]

Parental opposition to their infant's clinical data collection [+1]

Status: Recruiting

Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants

Very preterm neonates (born before 32 weeks' gestation) often require invasive mechanical ventilation (IMV) to manage respiratory insufficiency. In France, around 8,250 infants are born annually at \<32 weeks, with an estimated 5,000 needing IMV. Although non-invasive support such as continuous positive airway pressure (CPAP) has become more common, a substantial proportion of these neonates still transition to IMV within the first few days of life. To reduce lung injury and the incidence of bronchopulmonary dysplasia (BPD), a key strategy in neonatal intensive care involves limiting the duration of IMV and promoting earlier extubation. However, effective sedation and analgesia are essential for preterm infants subjected to intubation and mechanical ventilation. Traditionally, neonatologists combine a sedative (frequently midazolam) with an opioid (morphine, fentanyl, or sufentanil). Although these agents control pain and distress, they may cause respiratory depression, complicate weaning, and potentially contribute to adverse long-term outcomes. Midazolam, one of the few sedatives authorized for use in neonates, can improve comfort and sedation scores, but concerns persist about hypotension, altered cerebral perfusion, and a possible link to intraventricular hemorrhage (IVH). Moreover, combining benzodiazepines and opioids can prolong ventilation, increase the risk of complications, and impede timely extubation. Rationale for Dexmedetomidine (DEX) Dexmedetomidine (DEX) is a highly selective α2-adrenergic agonist that offers sedative, anxiolytic, and analgesic properties with relatively minimal respiratory depression. Unlike certain other sedatives, DEX induces a state akin to natural sleep, allowing for easier arousal and potentially better respiratory drive. Animal studies suggest that DEX might be neuroprotective, reducing inflammation, oxidative stress, and apoptotic processes that can be detrimental to the developing brain. These features make DEX a promising alternative to the commonly used benzodiazepine-opioid regimens in very preterm neonates, who remain especially vulnerable to adverse drug effects. Minimizing Invasive Mechanical Ventilation Reducing the time on IMV is crucial for preventing ventilator-induced lung injury and decreasing the likelihood of BPD. Early extubation is a central goal in this population, but sedation-related respiratory depression can thwart successful weaning and lead to reintubation. By preserving spontaneous breathing more effectively than midazolam or high-dose opioids, DEX may help neonates maintain adequate ventilation as they transition to non-invasive support. Furthermore, DEX's analgesic action could reduce the need for opioids, thereby mitigating withdrawal risks and other opioid-related complications such as feeding intolerance and extended hospital stays. Objective of the DEXPRE Trial The objective of the DEXPRE trial is to compare the efficacy of dexmedetomidine-based sedation with that of midazolam-based sedation in very preterm neonates requiring IMV. Specifically, investigators aim to determine whether DEX can facilitate more rapid extubation and better overall respiratory outcomes compared to midazolam. By systematically evaluating sedation quality, respiratory stability, and potential side effects, the trial seeks to generate evidence that will guide future sedation protocols in neonatal intensive care units.

Participants needed: 380
Trial details
Phase: Phase 3Age: Up to 32Biological sex: AllType: InterventionalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Feb 10, 2026Locations: 1
Eligibility criteria

Patient admitted in NICU (intubated or not yet), [+13]

Patient admitted in NICU (intubated or not yet), [+2]

Status: Not yet recruiting

The Effect of Cranial Osteopathy Intervention in Preterm Babies

There are planing to have 2 groups of premature born cases. Each group will include 15 cases. Participants are need to be 28-37 weeks born and no older than post term 6 weeks. All cases are going to be evaluated. Home based exercise plan is going to be explained. The experimental group is going to take 6 osteopathic sessions weekly. After 6 weeks cases are going to be evaluated again.

Participants needed: 30
Trial details
Age: 1-6Biological sex: AllType: InterventionalSponsor: Abant Izzet Baysal UniversityUpdated: May 13, 2025Locations: 1
Eligibility criteria

Premature birth (<37 weeks) [+4]

Having a congenital cyanotic heart problem, [+6]

Status: Not yet recruiting

Neonatologist-Performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy

The goal of this cross-over clinical trial is to evaluate whether Neonatologist-Performed Lung Ultrasound (NPLUS) can be used in preterm babies on non-invasive breathing support to reduce the amount of oxygen they need. The main question it aims to answer is: When a baby's oxygen requirement goes up, does NPLUS help to target interventions and reduce oxygen requirements? Researchers will compare NPLUS to standard treatment. Participants will: Have a lung ultrasound performed whenever their oxygen requirement increases by more than 10%. The ultrasound findings will be used to target interventions that aim to improve air entry in the lungs. Each time this happens, the researchers will note what happens to the oxygen requirement afterwards. Each participant will participate for five days. For the first two days, they will be randomized to either the NPLUS arm or the usual care arm. There is then a 24 hour period of usual care. For the final two days, participants cross over to the other arm of the trial.

Participants needed: 20
Trial details
Age: 1+Biological sex: AllType: InterventionalSponsor: Royal Hospital For WomenUpdated: Mar 28, 2025Locations: 1
Eligibility criteria

All preterm infants (<33 weeks gestational age) from their 2nd week of life, rec... [+2]

Neonates with previous abdominal surgery [+6]

Status: Not yet recruiting

Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance Using Fecal Lipocalin-2 and Electrical Cardiometry

Prospective observational study to evaluate the efficiency of using electrical cardiometry in combination with fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance

Participants needed: 42
Trial details
Age: 1-28Biological sex: AllType: ObservationalSponsor: Ain Shams UniversityUpdated: Mar 13, 2025Locations: 1
Eligibility criteria

Chromosomal anomaly or multiple congenital malformations. [+2]

Status: Not yet recruiting

The Effect of Massage on Preterm Babies

This study was planned as a randomized controlled experimental study with pre-test post-test design in order to examine the effect of massage on pain, comfort and nutritional status in infants undergoing NCPAP in the NICU, considering that massage may be effective in reducing the effectiveness of treatment and complications that may develop due to NCPAP by reducing stress in newborns undergoing NCPAP.In this research, answers to the following questions will be sought; Massage has an effect on pain in preterm infants receiving NCPAP therapy; H1: has an effect on pain. H2: has an effect on comfort. H3: has an effect on feeding intolerance (vomiting, abdominal distension, stool output...)

Participants needed: 30
Trial details
Age: 32-37Biological sex: AllType: InterventionalSponsor: Özlem BOZBUĞAUpdated: Jan 29, 2025
Eligibility criteria

Infants of parents who agreed to participate in the study, [+4]

• Infants with necrotising entecolitis, suspected or confirmed sepsis, [+5]

Status: Not yet recruiting

Using NIRS to Evaluate Splanchnic Oxygenation During Blood Transfusion in Preterm Infant

To evaluate the differences splanchnic oxygen saturation in preterm infants receiving red blood cell transfusion with and without enteral feeding, and their outcomes.

Participants needed: 42
Trial details
Biological sex: AllType: InterventionalSponsor: Gadjah Mada UniversityUpdated: Oct 29, 2024Locations: 1
Eligibility criteria

Infant with gestational age < 37 weeks [+3]

Infant with multiple congenital anomalies [+2]

Status: Not yet recruiting

Effect of Nursing Interventions on Pain and Salivary Cortisol Levels During Heel Stick in Preterm Newborns

Babies born before the thirty-seventh gestational week are called preterm or premature. Most preterm newborns require Neonatal Intensive Care Unit (NICU) care depending on their gestational age and clinical condition. Although many painful invasive procedures are usually performed on newborns in the NICU, the most common procedure is heel prick. Heel prick is a painful and stressful procedure for the newborn. Neonates do not respond to pain verbally; they respond physiologically, behaviorally and hormonally. Physiologic responses of preterm infants to pain include increased heart and respiratory rate, increased blood pressure and intracranial pressure, decreased oxygenation, and sweating of palms. Among the hormonal symptoms caused by stress in newborns, the most commonly used biochemical method is the measurement of cortisol level. It is reported that there is a significant correlation between salivary and plasma cortisol levels and salivary cortisol level reflects plasma cortisol level. This method is particularly preferred because saliva sampling is much less stressful.

Participants needed: 18
Trial details
Age: 34-36Biological sex: AllType: InterventionalSponsor: Namik Kemal UniversityUpdated: Oct 4, 2024
Eligibility criteria

Mother 18 years of age or older [+9]

The baby has a fever [+7]