Premature

19

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

Condition / disease
Location
Status: Recruiting

Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial

Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.

Participants needed: 152
Trial details
Age: 24-72Biological sex: AllType: InterventionalSponsor: University of Alabama at BirminghamUpdated: Jun 15, 2026Locations: 1
Eligibility criteria

Gestational ages between 22 0/7 - 32 6/7 weeks gestation [+1]

Major congenital/chromosomal anomalies [+1]

Status: Not yet recruiting

Automated Oxygen Control in Preterms on Non-invasive Ventilation

This randomised controlled trial aims to investigate the effectiveness of closed-loop automated oxygen control (CLAC) in preterm infants receiving non-invasive respiratory support and determine if it reduces the duration of supplementary oxygen treatment and improves achievement of oxygen saturation targets, reduces the incidences of hypoxia and hyperoxia, the number of manual adjustments to the inspired oxygen concentration (FiO2), and adverse outcomes including bronchopulmonary dysplasia (BPD). The study will take place at King's College Hospital neonatal intensive care unit (NICU). Parents of preterm infants born at less than 34 weeks of gestation and receiving non-invasive respiratory support will be approached, informed and if appropriate consented to join the trial. Participants will be randomised to receiving either automated or manual oxygen control. The study will measure outcomes including the duration of supplementary oxygen treatment, the percentage of time spent within oxygen saturation targets, the incidences of hypoxia and hyperoxia, the number of manual FiO2 adjustments required, the overall duration of non-invasive respiratory support and length of neonatal unit stay, and the incidence of BPD at 36 weeks postmenstrual age (PMA). Results will be compared between the two groups.

Participants needed: 76
Trial details
Age: 22-34Biological sex: AllType: InterventionalSponsor: King's College Hospital NHS TrustUpdated: Jun 3, 2026Locations: 1
Eligibility criteria

non-invasive positive pressure ventilation (NIPPV) [+2]

Infants with congenital cyanotic heart disease. [+1]

Status: Recruiting

Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates

Respiratory morbidity presents a significant clinical challenge in the neonatal period, and an individual patient's clinical course is often difficult to predict. This is especially true for late-preterm infants, who share some of the same risks of premature babies in terms or respiratory morbidity, but whose births may not always be attended by a neonatologist, or who may be born at hospitals with lower level Neonatal Intensive Care Units (NICUs) and require transfer if they decompensate. With this study, the aim is to 1) determine the efficacy of early point of care lung ultrasound (LUS) to predict respiratory decompensation in the first 48 hours of life in late preterm infants and 2) to compare the performance of three lung ultrasound scoring systems, 3 type-of-lung, high risk pattern and total LUS scoring systems.

Participants needed: 300
Trial details
Age: 34-36Biological sex: AllType: ObservationalSponsor: Hackensack Meridian HealthUpdated: May 22, 2026Locations: 1
Eligibility criteria

Inborn infants born between 34w0d and 36w6d gestational age [+2]

Patients born <34 weeks or >36w6d [+4]

Status: Not yet recruiting

Effect of Rectal Administration of Breast Milk on Gut Microbiota in Preterm Infants

This study aims to evaluate the effect of rectal administration of maternal breast milk on gut microbiota development in preterm infants. Preterm infants are at increased risk of dysbiosis due to immaturity and limited enteral feeding in the early postnatal period. In this randomized controlled study, preterm infants will receive either rectal administration of maternal breast milk or normal saline. The primary objective is to compare gut microbiota composition between the two groups. The findings may provide insight into a novel and non-invasive strategy to support microbiota development in preterm infants.

Participants needed: 60
Trial details
Age: 22-32Biological sex: AllType: InterventionalSponsor: Zekai Tahir Burak Women's Health Research and Education HospitalUpdated: Apr 30, 2026
Eligibility criteria

Not listed

Status: Not yet recruiting

Reactions to Oro-facial Solicitations : a Predictor of Eating Difficulties for Premature Babies of 36 Weeks Gestation Adjusted Age

The goal of this observational study is to assess the link between reactions to orofacial stimuli observed at 29 weeks of amenorrhoea, and feeding difficulties at 36 weeks of amenorrhoea, in babies born prematurely between 26 and 27 + 6 weeks of gestation, admitted to the CHSF between 1 May 2025 and 31 March 2026. The main questions it aims to answer are : Can reactions to orofacial stimulation in babies born very prematurely be used as a tool for early detection of feeding difficulties before discharge from hospital? Is it possible to establish a predictive score for potential feeding difficulties as early as 29 weeks of gestation corrected, based on reactions to orofacial stimuli ? Participants will have their reactions to orofacial stimulations recorded in the 'Suivi oralité' grid completed by the nurses in the neonatal medicine and intensive care unit, which will then collect.

Participants needed: 80
Trial details
Age: 26-28Biological sex: AllType: ObservationalSponsor: Centre Hospitalier Sud FrancilienUpdated: Mar 27, 2026Locations: 1
Eligibility criteria

Premature babies born between 26 and 27 + 6 weeks of gestation [+3]

ENT malformation [+6]

Status: Not yet recruiting

Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants

This study compares three approaches to help premature babies learn to feed by mouth: a special mouth exercise program (called PIOMI), using a pacifier, and standard care. Premature babies often have difficulty feeding because their sucking, swallowing, and breathing are not yet coordinated, which can lead to longer hospital stays. The study will include 150 premature infants born between 26 and 32 weeks of pregnancy at a hospital in Thi Qar. Babies will be randomly placed into one of three groups: one group will receive a many-day mouth exercise program, another will use a pacifier for many days, and the third will receive routine care. We will measure how quickly each baby learns to feed fully by mouth, how long they stay in the hospital, how much weight they gain, and their feeding skills. The results may help improve care for premature babies and reduce the time they spend in the hospital.

Participants needed: 150
Trial details
Age: 1-28Biological sex: AllType: InterventionalSponsor: University of BaghdadUpdated: Mar 10, 2026Locations: 1
Eligibility criteria

- Preterm infants born at 26-32 weeks of gestational age [+3]

Orofacial malformations (e.g., cleft lip, cleft palate) [+5]

Status: Recruiting

Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates

This study aims to study the effect of lactase enzyme in preventing feeding intolerance in preterm neonates in neonatal intensive care unit at Alexandria University Children's Hospital.

Participants needed: 120
Trial details
Age: 3-1Biological sex: AllType: InterventionalSponsor: Alexandria UniversityUpdated: Jan 16, 2026Locations: 1
Eligibility criteria

Preterm neonates ≤ 32 weeks gestational age. [+1]

Parental consent lacking/refusal. [+5]

Status: Recruiting

Evaluation of Placental Transfusion Techniques in Prevention of Prematurity Related Complications and Effect on Their Hematological Profile

The objective of this study is to evaluate the general course and prognosis associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life

Participants needed: 160
Trial details
Age: 1-2Biological sex: AllType: InterventionalSponsor: Alexandria UniversityUpdated: Jan 16, 2026Locations: 1
Eligibility criteria

Premature neonates ≤ 32 weeks gestational age regardless birth weight [+1]

Major congenital anomalies (complex cyanotic heart disease, major central nervou... [+4]

Status: Recruiting

Baby ABS (Abdominal Binder Study)

The primary outcome of this study is to determine if the use of the FDA-approved DandleLion NeoBellyBand increases the thickness of the rectus abdominis muscle in premature babies receiving continuous positive pressure ventilation, leading to infants reaching full oral feedings at an earlier corrected gestational age.

Participants needed: 40
Trial details
Age: 26-31Biological sex: AllType: InterventionalSponsor: University of MinnesotaUpdated: Sep 26, 2025Locations: 1
Eligibility criteria

Premature viable neonates with corrected gestational age of 26-31 weeks [+1]

Outside of gestational age at birth [+7]

Status: Recruiting

Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants

A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.

Participants needed: 328
Trial details
Age: Up to 36Biological sex: AllType: InterventionalSponsor: The University of Texas Health Science Center at San AntonioUpdated: Sep 24, 2025Locations: 7
Eligibility criteria

born between 25 0/7 and 29 6/7 weeks of gestation [+1]

serious congenital anomalies [+2]

Status: Recruiting

Triglycerides Glucose Index on Angiographic Profiling of Non-Diabetic Premature Coronary Artery Disease Patients

This study aims to evaluate the impact of the triglyceride-glucose (TyG) index on the angiographic profiling of non-diabetic patients with premature coronary artery disease (CAD).

Participants needed: 180
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Sohag UniversityUpdated: Sep 5, 2025Locations: 1
Eligibility criteria

Age ≥18 years old. [+3]

Known diabetes mellitus (type 1 or type 2). [+4]

Status: Recruiting

Growing Little PEAPODS Study

The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth and development. Participants will: * have body growth measurements collected using the PEAPOD device * have nutritional information collected, and * be followed for neurodevelopmental outcomes Participants can expect to be in the study for 36 months.

Participants needed: 120
Trial details
Age: 22-32Biological sex: AllType: ObservationalSponsor: University of Wisconsin, MadisonUpdated: Aug 12, 2025Locations: 1
Eligibility criteria

Born inpatient at Meriter Hospital, Inc. at or above 22 gestational weeks. Upper...

Known genetic condition that impacts neurodevelopmental outcomes or brain struct... [+11]

Status: Not yet recruiting

Post-extubation Use RAM Cannula Versus Short Binasal Prong Interfaces in Preterm Infants

Nowadays, the use of non-invasive ventilation for preterm infants in the NICU has increased to avoid complications associated with prolonged endotracheal intubation. Adequate pressure delivery through non-invasive ventilation is essential, as it enhances the growth and development of premature lungs. Various interfaces have been used to ensure proper sealing. The RAM cannula, used as an interface for non-invasive respiratory support in preterm neonates, is associated with reduced nasal trauma compared to short binasal prongs (SBPs), due to its softer material, making it a safer option. However, the RAM cannula has been shown to deliver lower pharyngeal pressure and, therefore, may not maintain airway pressure as consistently as nasal prongs. Currently, limited data is available regarding the efficacy of nasal prongs compared to the RAM cannula as a post-extubation interface for non-invasive ventilation support in preterm infants. Additionally, we have observed that the use of the RAM cannula for non-invasive ventilation in preterm infants is associated with a longer duration of oxygen therapy compared to SBPs. The investigators hypothesize that the RAM cannula provides a lower level of positive end-expiratory pressure compared to SBPs during non-invasive ventilation. The investigators aim to assess the efficacy and safety of the RAM cannula versus SBPs as nasal interfaces for post-extubation non-invasive respiratory support in preterm infants.

Participants needed: 90
Trial details
Age: 24-28Biological sex: AllType: InterventionalSponsor: Ministry of Health, Saudi ArabiaUpdated: Aug 8, 2025Locations: 1
Eligibility criteria

Inborn preterm neonates ≤ 32 weeks of gestational and/or birth weight ≤1500 g wi...

Outborn preterm neonates [+1]

Status: Recruiting

Magnetoencephalography by Optical Pumping Magnetometer

MagnetoEncephaloGraphy (MEG) is a method of recording brain activity with high temporal resolution and good spatial resolution, compared to current recording techniques such as ElectroEncephaloGraphy (EEG). The main limitation of MEG is its cost due to the sensors used, the Super Quantum Interference Devices (SQUID). These require a complex infrastructure from an instrumentation point of view to operate, requiring liquid helium, most often at a loss, at increasing cost. Optical Pumping Magnetometers (OPM) type sensors represent a promising alternative to SQUIDs sensors, especially since they do not require helium cooling. The purpose of this project is to Identify biomarkers in Magnetoencephalography of normal brain development in healthy adults, premature and term newborns from "a priori" obtained by the classical technique of High Resolution EEG performed.

Participants needed: 70
Trial details
Age: 1+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: May 28, 2025Locations: 1
Eligibility criteria

For healthy adult volunteers [+12]

Subject and Patients "not compatible" MEG. Wearers of prosthesis or pacemaker li... [+3]

Status: Recruiting

Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study

This study is a multi-center, prospective pre-post clinical study conducted under the leadership of the Turkish Neonatal Society. It aims to investigate the effects of a standardized skin-to-skin care in NICU, initiated early and applied regularly, on recieving exclusive mothers' milk at discharge and clinical outcomes for preterm infants born ≤ 32 weeks of gestation. 1. Primary Objective: To evaluate the rate of receiving exclusive mothers' milk at discharge for infants born ≤ 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol. 2. Secondary Objective: To evaluate the rates of neonatal sepsis, intraventricular hemorrhage, and necrotizing enterocolitis (stage 2 and above) as well as the length of hospital stay for infants born at or below 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.

Participants needed: 120
Trial details
Age: 1+Biological sex: AllType: InterventionalSponsor: Baskent University Ankara HospitalUpdated: Nov 4, 2024Locations: 1
Eligibility criteria

Infants born at gestational age ≤ 32 weeks

Death before NICU discharge [+1]

Status: Recruiting

Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.

The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.

Participants needed: 500
Trial details
Phase: Phase 3Age: 6-10Biological sex: AllType: InterventionalSponsor: Franciscus GasthuisUpdated: Aug 22, 2024Locations: 1
Eligibility criteria

Gestational age at delivery between 30+0 and 35+6 weeks [+2]

Underlying other severe respiratory disease such as broncho-pulmonary dysplasia... [+5]

Status: Recruiting

dTDI During a SBT to Predict Extubation Failure in Preterm Infants

Weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue Doppler analysis in both inspiration and expiration.

Participants needed: 100
Trial details
Age: 2-6Biological sex: AllType: ObservationalSponsor: Wang JianhuiUpdated: Jul 16, 2024Locations: 1
Eligibility criteria

premature infants with gestational age <32 weeks and supported by invasive mecha... [+3]

accidental extubation [+8]

Status: Recruiting

Enteral Feeding of Premature Babies and Olive Oil Supplementation

It is a two-arm prospective interventional study. 40 babies in both groups will be enrolment in the study. In the intervention group, babies will take 1 ml/kg/day of the study product (ULTRA PREMIUM) after full enteral feeding. Supplementation will continue until discharge or the 36th week. Blood samples will be taken for serum Total antioxidant capacity and Malondialdehyde levels before the intervention and on the 14th day of the control group. At the end of the study, serum will be taken again for control values. Daily lipid intake amounts will be recorded through breast milk analysis. Lipid profile will be monitored weekly The growth parameters of babies will be monitored daily It will be evaluated at the end of the study in terms of ROP, BPD, and NEC. At the end of the study, the data of babies in both groups will be compared.

Participants needed: 80
Trial details
Age: 14-40Biological sex: AllType: InterventionalSponsor: Bursa City HospitalUpdated: Jul 15, 2024Locations: 1
Eligibility criteria

Premature babies born at 32 weeks or less [+2]

Having a congenital or genetic anomaly

Status: Recruiting

Effects of the Application of PIOMI in the Oral Feeding of Premature

The goal of this clinical trial is assess whether the application of the premature oral motor intervention (PIOMI) combined with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP), allows withdrawal of the external feeding device with guarantees of the patient's nutritional status, determining breastfeeding rates at hospital discharge and swallowing safety earlier than if only the care activity corresponding to the NIDCAP model is carried out, as well as the applicability of this standardised protocol in the neonatal intensive care unit of a tertiary hospital.

Participants needed: 35
Trial details
Age: 29-30Biological sex: AllType: InterventionalSponsor: Fundació Sant Joan de DéuUpdated: May 2, 2024Locations: 1
Eligibility criteria

Neonates born at the Sant Joan de Déu Hospital with a gestational age between 29...

Endotracheal intubation or high-flow ventilatory support. [+3]