Effect of Oral Erythropoietin on tolerance of oral feeding, Prevention of Complications and reduction of mortality in neonatal with hypoxic ischemic encephalopathy

The effect of oral erythropoietin on oral nutrition tolerance, prevention of complications and reduction of mortality in neonates with ischemic hypoxic encephalopathy

Affected infants will be randomly divided into control and intervention groups. The intervention group will include infants who will be given oral erythropoietin at a dose of 400 units / kg daily within the first 48 hours of birth and for 5 days. The control group will receive standard asphyxia and placebo treatments. Normal saline will be given as a placebo in the same amount of oral or gastric catheter. Finally, the two groups in terms of oral feeding tolerance (feeding start time, 100 cc / kg full feeding time) will be considered as the primary outcome.

Neonates with a gestational age greater than and equal to 37 weeks (semesters and near semesters) and without structural anomalies during 1400-1699 in NICU of Imam Reza Hospital with HIE (ischemic hypoxic encephalopathy) grade 2 or 3, which is based on clinical and laboratory criteria.

Inclusion criteria: Gestational age more than or equal to 37 weeks, perinatal asphyxia, grade 2 and 3 encephalopathy Exclusion criteria: Birth weight <2200 g, A genetic or congenital disease that affects nerve growth or requires multiple surgeries, Head circumference <30 cm, Polycythemia, The infant should participate in another intervention period during hospitalization, Asphyxia cases without HIE, Metabolic diseases, Confirmed infection

The intervention group will include infants who will be given oral erythropoietin ampoules at a dose of 400 units / kg daily within a maximum of 48 hours of birth and will be prescribed for 5 days.

The two groups in terms of oral feeding tolerance (feeding start time, time to complete feeding 100 cc / kg) as primary outcome will be considered

The study design is done in parallel in which the two groups are compared over time. The simple randomization method is using a table of random numbers using the site www.randomization.com. Concealment is done through sealed envelopes. The method of the envelope is that the envelopes will be prepared and printed by a member of the research team and random numbers with the help of Randomaize.com and placed inside the envelope. The lid of the envelope will be closed and its contents will not be visible from the outside. Then, the purpose of the study is first explained to the person who meets the conditions, and the person, if he wishes, signs the informed consent form and takes an envelope, and then opens it and enters the intervention or control group based on the contents of the envelope.

The subjects and evaluators will be unaware of the intervention and control groups

All data can be shared after patients are made unidentified.

Data can be accessible 6 months after results are published

data can be accessible through an email to the corresponding author

Data will be available for researchers in universities and other scientific institution.

After sending a request email to the corresponding author, data will be sent in 1 month.

Carrying out analysis on data is permitted