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NEC clinical trials

View clinical trials related to NEC.

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NCT ID: NCT05734118 Not yet recruiting - Clinical trials for Intestinal Perforation

Safety and Feasibility of Indocyanine Green Fluorescence for Intraoperative Assessment of Intestinal Perfusion in Young Infants and Neonates

IMAGINE
Start date: August 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the use of the SPY-PHI device for the purpose of ICG-mediated intestinal perfusion visualization during gastrointestinal surgery in neonates and young infants (<3 months old) undergoing surgery for NEC, atresia, SIP or malrotation. The main question[s] it aims to answer are: - Is ICG-FA feasible for intraoperative use in neonates and young infants undergoing laparotomy for NEC, atresia, SIP or malrotation? - Is ICG-FA is safe to use in neonates during surgery? Participants will undergo surgical care for their diseases within the standard of care. During laparotomy, the pediatric surgeon will assess bowel perfusion in two ways. First, by visual inspection (the conventional method). Second, the intestine will be analyzed with indocyanine green fluorescence angiography (ICG-FA) by means of the hand-held SPY-PHI camera. For this purpose, the patients will be administered ICG intravenously. Afterwards, the intestinal perfusion will be assessed by means of the SPY-PHI device in 5 to 10 minutes. Specifically, the feasibility and safety for use of ICG-FA in neonates undergoing laparotomy as treatment for necrotizing enterocolitis (NEC), atresia, spontaneous intestinal perforation (SIP) and malrotation will be investigated. If ICG-FA turns out to be feasible and safe for the population investigated in this study, a follow-up study will be conducted with the aim to explore the potential benefits of this technique on the postoperative outcome and intraoperative decision-making.

NCT ID: NCT05636397 Recruiting - Clinical trials for Pulmonary Hypertension

Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and explore the PK/PD of L-CIT supplementation in preterm infants to prevent the development of inflammatory pathways initiated by low levels of plasma CIT, specifically in preterm infants with post surgical NEC and BPD±PH.

NCT ID: NCT05293353 Recruiting - Preterm Clinical Trials

Neokare Safety and Tolerability Assessment in Neonates With GI Problems

Start date: June 9, 2022
Phase:
Study type: Observational

With an increasing body of evidence to support a causal link between drinking milk that contain cow's milk protein (CMP) and the development of gastrointestinal disturbance in infants, many clinicians avoid the use of CMP containing feed in high risk babies. Delivery of adequate nutritional intake is one of the great challenges in the care of newborn infants, particularly those born preterm or with gastrointestinal problems. Whilst there are recognised benefits of human milk, a diet of exclusive human milk may not meet the nutritional demands of the infant. To close this gap, breast milk fortifier (BMF) is typically added to human milk. However, addition of BMF may be associated with gastrointestinal disturbance, possibly due to the fact that it contains CMP. This research study is to test the tolerability and safety of a new human milk-based BMF in neonates with gastrointestinal problems. It is hoped that this may provide an opportunity for high risk infants, to receive the benefits of human milk whilst minimising the risks reported to be associated with CMP. Eligible infants will be those in whom nutritional supplementation of breast is deemed clinically necessary, a weight of greater than 1.0kg at the time of starting fortifier and at least one of: - previous gastrointestinal surgery - congenital gastrointestinal anomaly - medically treated gastrointestinal disease - previously suspected intolerance of CMP based breast milk fortifier in the absence of other gastrointestinal disease Infants will be started on human milk-based BMF once they are tolerating 100 mls per kilo per day of human breast milk. The human milk-based fortifier will be commenced at half the recommended dose for 48 hours then increase to full strength. This will be continued until the infant reaches 44 weeks corrected gestational age, or until such time as they are deemed to no longer require the additional nutrition.

NCT ID: NCT05278247 Not yet recruiting - NEC Clinical Trials

Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)

(Songbird)
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2). Near infrared spectroscopy (NIRS) is a technique available to non-invasively and safely monitor the tissue oxygenation status (StO2), which can be beneficial or live saving for this fragile patient population. Unfortunately, traditional NIRS devices show a broad variability when applied to the abdomen (Bailey & Mally 2016). The novel device is designed especially for application of NIRS on the abdomen of preterm infants.

NCT ID: NCT04886674 Not yet recruiting - NEC Clinical Trials

Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates

Start date: July 1, 2021
Phase:
Study type: Observational

Primary Aim: The aim of this study is to investigate the efficacy of bovine colostrum in prevention of necrotizing enterocolitis (NEC) and sepsis in very low birth weight (VLBW) infants. Secondary Aim: To improve outcomes of neonatal sepsis and NEC in the pe-terrms and to decrease their hospital stay.

NCT ID: NCT04313933 Completed - NEC Clinical Trials

Plasma Citrulline in Preterm With NEC

NEC
Start date: March 12, 2019
Phase:
Study type: Observational [Patient Registry]

Aim of study

NCT ID: NCT04004091 Completed - Premature Birth Clinical Trials

Prenatal Administration of Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Fetal Rabbit

Start date: March 1, 2019
Phase: Early Phase 1
Study type: Interventional

Infections, particularly on the gastrointestinal tract, has been known to be one of the leading causes of death in preterm infants. This is due to the immaturity of the intestinal epithelial cells. Recent studies have shown that polyamines have a role on the development of cells during embryonal phase. By this experimental study, the investigators would like to evaluate the administration of spermine on the maturation of premature fetal gut epithelial tight junction.

NCT ID: NCT02192996 Completed - Clinical trials for Other Preterm Infants

Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight Preterm, a Pilot Study

Start date: December 2012
Phase: Phase 0
Study type: Interventional

This pilot trial is designed to investigate the benefits of the use of probiotics in GUT microbiota development and/or immunological biomarkers and how this can be related with the clinical status of very low birth weight preterms during their first weeks of life at the neonatal intensive care unit(NICU).

NCT ID: NCT01263041 Completed - Sepsis Clinical Trials

Effect of L-arginine and Glutamine on Preterm

preterm
Start date: May 2011
Phase: Phase 2/Phase 3
Study type: Interventional

effects of enteral l-arginine to decrease feeding intolerance and risk of NEC in neonates via its role as a NO precursor. Also, enteral glutamine which may play a role as an immunomodulator on preterm neonates. all these had never been studied in developing countries where sepsis and nec act as a major participant in mortality rates.