Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Infections

Premature Birth

Necrosis

Sepsis

Toxemia

Communicable Diseases

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Vitamin D

Cholecalciferol

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 800 IU from the time of diagnosis of sepsis until discharge from the NICU

Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 400 IU from the time of diagnosis of sepsis until discharge from the NICU

High-dose vitamin D 3

Conventional-Dose Vitamin D 3

This is a randomized controlled trial (RCT) to evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of these infants.

Vitamin D has an important role in the regulation of both the innate and adaptive immune systems. There are very few studies of such roles in the neonatal population. It is potentially an attractive therapeutic agent for sepsis given its low cost and low risk of toxicity and side effects. There is no consensus regarding to the dose of vitamin D supplementation required for preterm infants given the paucity of evidence. AAP and ESPGHAN have recommended different dosages of vitamin D ranging from 400 IU to 1000 IU per day. The influence of different doses of vitamin D on immunological status and clinical outcomes of preterm infants with late-onset sepsis has not been evaluated before. This RCT will evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis we will also evaluate their safety and influence on clinical outcomes of these infants

A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis

Effect of Different Dosages Oral Vitamin D on Serum Interleukin-6 in Preterm Infants With Late-onset Sepsis

Serum levels of interleukin-6 (IL-6) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy. IL-6 concentrations will be determined by Endogenous Interleukin-ELISA

Serum levels of tumor necrosis-alpha (TNF-alpha) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy

Serum CRP will be evaluated at enrollment and 7 days

Serum 25(OH)D levels will be measured by ELISA at trial entry, at day 7 and at 40 weeks postmenstrual age

Participants will be followed for the duration of hospital stay, serum calcium, phosphorus and urinary calcium well be assessed every week for an expected average of 5 weeks

Abdominal ultrasonography to detect any nephrocalcinosis will be done at 40 weeks postmenstrual age

In-hospital mortality during NICU admission for an expected average of 5 weeks

Participants will be followed for the duration of hospital stay, for an expected average of 5 weeks and the incidence of neonatal morbidities e.g. NEC, retinopathy of prematurity, disseminated intravascular coagulopathy and renal dysfunction will be assessed

Mansoura University Children Hospital

Professor of Pediatrics

Nervous System Diseases

Wounds and Injuries

Rare Diseases

Death

Cerebral Palsy

Body Weight

Paralysis

Birth Weight

Brain Injuries

Brain Diseases

Central Nervous System Diseases

Craniocerebral Trauma

Trauma, Nervous System

Brain Damage, Chronic

Chronic Graft Versus Host Disease

Anti-Inflammatory Agents

Antineoplastic Agents

Analgesics

Interleukin-2

William Oh, MD

Michele C. Walsh, MD MS

Ronald N. Goldberg, MD

Barbara J. Stoll, MD

James A. Lemons, MD

Abhik Das, PhD

David K. Stevenson, MD

Waldemar A. Carlo, MD

Neil N. Finer, MD

Edward F. Donovan, MD

Shahnaz Duara, MD

Lu-Ann Papile, MD

Sheldon B. Korones, MD

Jon E. Tyson, MD MPH

Abbot R. Laptook, MD

T. Michael O'Shea, MD MPH

Seetha Shankaran, MD

Richard A. Ehrenkranz, MD

This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at 18-22 months corrected age.

Inflammatory cytokines \[interleukin-1 (IL-1β), IL-8, IL-9, tumor necrosis factor-α (TNF-α), and RANTES\] but not anti-inflammatory cytokines released during the perinatal period have been associated with the development of periventricular leukomalacia (PVL) and cerebral palsy (CP) in near term and term infants. However, because blood samples were obtained on any day between day 1 and 18, these data cannot distinguish between prenatal and postnatal effects on neurological outcome. Furthermore, very low birth weight infants who are at the highest risk have not been studies.

The goal of this study was to measure pro-inflammatory and anti-inflammatory cytokine levels at various times in the perinatal period (at birth up to day of life 21), since they may be elevated at different points in the disease process. Blood samples (whole blood spots, dried on filter paper) were obtained on day 1 within 4 hours after birth, and on days 3, 7, 14, and 21. Neurodevelopmental assessments were conducted at 18-22 months corrected age.

Whole blood spots collected on filter paper.

Inflammatory Cytokines Associated With Perinatal Brain Injury

A Study to Determine If Inflammatory Cytokines Are Associated With Perinatal Brain Injury and Long Term Neurodevelopmental Handicap or Death

Centers for Disease Control and Prevention

National Center for Research Resources (NCRR)

NICHD Neonatal Research Network

Waldemar A. Carlo, MD, Lead Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis	NCT02273843	Prematurity Late-onset Seps...	High-dose vitam... Conventional-Do...	3 Days - 28 Days	Mansoura University Children Hospital
Inflammatory Cytokines Associated With Perinatal Brain Injury	NCT01035697	Infant, Newborn Infant, Low Bir... Infant, Small f... Infant, Prematu... Cerebral Palsy		- 72 Hours	NICHD Neonatal Research Network
A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis	NCT02273843	Prematurity Late-onset Seps...	High-dose vitam... Conventional-Do...	3 Days - 28 Days	Mansoura University Children Hospital
Inflammatory Cytokines Associated With Perinatal Brain Injury	NCT01035697	Infant, Newborn Infant, Low Bir... Infant, Small f... Infant, Prematu... Cerebral Palsy		- 72 Hours	NICHD Neonatal Research Network

Spots Global Cancer Trial Database for prematurity

Every month we try and update this database with for prematurity cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for prematurity

Every month we try and update this database with for prematurity cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for prematurity cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.