Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201806003426116 Date of Approval: 29/05/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Enteral Erythropoietin on Feeding Related Complications in Preterm Newborns
Official scientific title The Effect of Enteral Erythropoietin on Feeding Related Complications in Preterm Newborns
Brief summary describing the background and objectives of the trial Prematurity is a major public health problem as it is a strong predictor of infant morbidity and morbidity and it is associated with a number of health problems. The severity of these problems is inversely correlated with gestational age and, therefore, the earlier in gestation an infant is born, the higher the risk of long-term problems. Feeding intolerance¿ (FI) usually refers to a combination of clinical signs suggesting an inability by the subject to tolerate enteral nutrition, The most comprehensive definition is as follows: ¿the inability to digest enteral feedings presented as gastric residual volume (GRV) of more than 50%, abdominal distension or emesis or both, and the disruption of the patient's feeding plan. In the preterm infant, the readiness to tolerate enteral nutrition depends on the degree of maturation of gastro intestinal functions (enzymatic digestion, motility, hormonal responses and local immunity). FI can be associated with necrotizing enterocolitis (NEC), a gastrointestinal emergency that remains a leading cause of morbidity and mortality in preterm infant. The aim of this work is to evaluate the effects of enteral administration of recombinant human erythropoietin (rhEPO) on feeding related complications in preterm infants.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Neonatal Diseases,Newborns with feeding intolerance and necrotizing enterocolitis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2015
Actual trial start date 29/07/2015
Anticipated date of last follow up 01/03/2017
Actual Last follow-up date 31/03/2017
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 72
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomi sation (variable block size) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Enteral rh EPO 88 IU/ Kg/day patient¿s enteral intake reached 150 mL/kg or after a maximum of 10 days. enteral intake 36
Control Group Distilled water patient¿s enteral intake reached 150 mL/kg or after a maximum of 10 days enteral intake 36 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
preterm infants born ¿ 32 weeks gestation in a cardiovascular stable condition infants who received chest compression or any medication given to the infant during resuscitation or any event suggesting exposure to hypoxia, infants with genetic syndromes, trisomies (13, 18...), inborn errors of metabolism (persistent metabolic acidosis, with history of multiple early sibling deaths or still births), infants with major congenital or acquired gastrointestinal tract malformation, infants with previous use of parenteral growth factors as: recombinant human erythropoietin & Granulocyte-macrophage colony-forming unit ( GM-CSF) and infants with previous use of intravenous immunoglobulin Infant: 13 Month(s)-24 Month(s) 30 Week(s) 32 Week(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/07/2015 IRB: Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Feeding intolerance in the form of abdominal distension ¿ 2 cm post feeding , vomiting (greater than three times in a 24-hour period) , coffee ground or bile stained vomiting Daily till 21 days
Primary Outcome Nnecrotizing enterocolitis Daily till 21 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Shatby Pediatric hospital, Alexandria university Portsaid street, El Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric departement faculyty of medicine, Alexandria University Portsaid street, El Shatby Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric departement faculyty of medicine, Alexandria University Portsaid street, El Shatby Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Naguib Massoud Portsaid street, El Shatby Alexandria 21526 Egypt
Hesham Ghazal Portsaid street, El Shatby Alexandria 21526 Egypt
Omneya Magdy Omar Portsaid street, El Shatby Alexandria 21526 Egypt
Mai Mohamed Fawzi Soma Portsaid street, El Shatby Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Massoud mnzmasoud@yahoo.com 00201001460224 El shatby hospital, port said street
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Pediatrics, Faculty of Medicine, University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Omneya Omar drmonymagdy@yahoo.com 00201223768859 El shatby hospital, port said street
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Lecturer of Pediatrics, Faculty of Medicine, University of Alexandria
REPORTING
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