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Neonate clinical trials

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NCT ID: NCT05045092 Withdrawn - Mortality Clinical Trials

A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China

Start date: January 1, 2024
Phase:
Study type: Observational

Descriptive study of two-year follow-up outcomes of surviving neonates who are enrolled in the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) from 2022 to 2024.

NCT ID: NCT04937348 Completed - Diabetes Mellitus Clinical Trials

Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.

Start date: December 13, 2019
Phase:
Study type: Observational

Diabetes mellitus is one of the most common metabolic disorders complicating the course of pregnancy, which concerns pre-pregnancy diabetes (PGDM) - most often type 1 or type 2; and gestational diabetes (GDM) - treated with diet (G1) or insulin (G2). Currently, in the pathogenesis of diabetes and the regulation of glucose metabolism, the role of tissue hormones, including adipokines, e.g., omentin-1, visfatin, have been considered. Adipokines might also affect the development of the fetus - mainly fetal adipose tissue gain. Their concentrations and activity depend on the maternal visceral fat content and concomitant metabolic disorders. It is known that adipokines are excreted in human milk during the lactation period. The aim of the study was to assess the impact of diabetes during pregnancy, requiring treatment with diet or insulin, on the nutritional status of the newborn.

NCT ID: NCT04905732 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD

Start date: May 20, 2021
Phase: N/A
Study type: Interventional

Invasive ventilation(IV) remains one key cornerstone to reduce neonatal mortality for preterm infants with respiratory distress syndrome(RDS) and/or acute respiratory distress syndrome(ARDS). However, it is also related to increased risks of ventilator-associated lung injury and escalation of pulmonary inflammation, and which finally result in bronchopulmonary dysplasia (BPD). Early weaning from IV in newborn infants with BPD is therefore a key procedure to reduce these risks above.

NCT ID: NCT04904965 Completed - Surgery Clinical Trials

Frontal Electroencephalography of Neonatal Patients Under Sedation With Opioids and General Anesthesia With Propofol.

Start date: May 3, 2021
Phase: N/A
Study type: Interventional

Frequently, neonates hospitalized in neonatology units require anesthesia for surgery. The drugs used for this purpose are opioids and other anesthetics, such as propofol. Currently, the administration of anesthesia is difficult in neonates due to the neurological immaturity of these patients, the scarcity of adequate pharmacological studies, the prolonged use of one or more sedatives prior to surgery and the limited usefulness of current anesthetic monitoring devices in this population. Electroencephalography (EEG), which has allowed estimation of anesthetic depth in other populations, has been less explored in neonates. To date, there are no EEG markers, correlated with a given dose of anesthesia, that allow an adequate administration in this kind of patients. In this context, a better understanding of the anesthetic effect in the neonatal brain would allow defining characteristic EEG patterns, improving the estimation of anesthetic depth and anesthetic dosage in neonates.

NCT ID: NCT04795453 Recruiting - Surgery Clinical Trials

Assessment of Score System of Surgery in Necrotizing Enterocolitis(NEC) Patients

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

Necrotizing enterocolitis(NEC) is one of the most serious disease in the newborn infants, and two and more grades of NEC usually lead to surgery, even death. But, it is difficult to predict when to operate the surgery.

NCT ID: NCT04794881 Completed - Meningitis Clinical Trials

Repeat Lumbar Puncture at 24 Versus 48 Hours After Traumatic Lumbar Puncture in Neonates

Start date: March 18, 2019
Phase: N/A
Study type: Interventional

Visibly traumatic as well as microtraumatic lumbar punctures (LP) are very common in the neonatal period. The presence of blood makes it difficult to interpret cerebro-spinal fluid (CSF) findings. Clinicians often perform a repeat LP in the hope that some of the red blood cells would have cleared by then, allowing a better interpretation of the CSF findings. There is no published information whether a repeat LP provides any added information to the original traumatic LP, and if so what is the best time to repeat an LP after a traumatic LP. In this randomised controlled trial (RCT), we plan to randomly allocate neonates following a visibly traumatic LP to either undergo a repeat LP at 24 hours or 48 hours later to determine which LP gives more accurate results.

NCT ID: NCT04464057 Completed - Infant Clinical Trials

Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

The study is primary designed to evaluate the safety and effectiveness of early feeding after bowel anastomosis, and observe the effect of early postoperative feeding on promoting postoperative rehabilitation and reducing parenteral nutrition

NCT ID: NCT04025021 Terminated - Neonate Clinical Trials

Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth. Breast milk analysis will occur on a weekly basis using the Miris Human Milk Analyzer. In the Control group, participants will receive standard TPN (total parenteral nutrition) and lipids and breast milk fortification according to MetroHealth's NICU guidelines. The Intervention group will receive TPN and lipids optimized depending on the results of breast milk analysis, followed by additional individualized fortification using additional microlipids and/or liquid protein to achieve the goal of 4g protein/kg/day and 100-130 kcal/kg/day.

NCT ID: NCT03103022 Completed - Clinical trials for Patent Ductus Arteriosus

Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus

Start date: June 12, 2017
Phase: Phase 1
Study type: Interventional

Patent ductus arteriosus or PDA is a blood vessel that connects the right and left side of the heart that usually closes after birth but remains open in some premature infants born before 30 weeks' gestation. When this blood vessel remains open for a long time, it may cause problems such as bleeding in the lung and brain, lung injury due to prolonged need of ventilator, and poor kidney function. It sometimes becomes necessary to close this blood vessel in the preterm infant. Currently, this blood vessel can be closed either by medication or surgery. Pain medications such as Ibuprofen and Indomethacin are routinely used medications to close PDA. However, in the last 5 year, acetaminophen has been found as an alternative medication to close PDA in preterm infants. In multiple studies, acetaminophen is found to be a safe alternative medication with lower side effects than current standard management. Intravenous Ibuprofen is approved by FDA to treat PDA in preterm infants. Although not approved by FDA, oral ibuprofen is being used for the management of PDA. However, the success rate of a single medication is approximately 70%. Both medications have been used in the previous clinical studies to treat the same condition in the preterm infants and fewer side effects were reported. Mechanism of both medications to close PDA is different and may work more effectively together than single medication alone. In this study, the investigator are going to use these two medications (Ibuprofen and Acetaminophen) at the same time if the child needs treatment and is eligible to participate in this study. This study is based on the assumption that by using both medications at the same time, investigator can close this blood vessel more effectively than with either drug alone.

NCT ID: NCT03082001 Completed - Pain Clinical Trials

Sucrose to Reduce Pain During Initiation of Venipuncture in Extremely Low Birth Weight Babies

Start date: January 1, 2011
Phase: Phase 3
Study type: Interventional

Newborn infants in the neonatal intensive care nursery experience multiple, painful tissue damaging procedures daily. Preterm especially extremely low birth weights and critically ill newborns admitted to a Neonatal Intensive Care Unit (NICU) undergo repeated skin-breaking procedures that are necessary for their survival. Sucrose is the accepted clinical standard nonpharmacological intervention for managing acute procedural pain for these infants. However its role in extremely low birth weight infants still need to be addressed. The exact dose and concentration of oral sucrose is still not clear. When a Medline search was carried out to evaluate the role of two different concentrations (12% vs 24%) of oral sucrose in reducing pain in extremely low birth weight babies, very limited data was available. Cochrane Systemic Review also indicated that specific attention to the efficacy and safety of sucrose administration in extremely low birth weight preterm infants needs to be further investigated. More so, no work on this aspect was identified from the Indian subcontinent. Hence, the current study was planned with an aim to study the effects of 12% and 24% oral sucrose in extremely low birth weight infants during initiation of venipuncture and also study the side effects if any associated with these concentrations. This is a preliminary work on this topic, the results would therefore need to be interpreted with caution. However, the findings and the study design of this work will provide suitable platform for future well powered studies on this population.