This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.
Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia
≥ 35. gestational week
< 48 hours of life
Hypothermia treatment for 72 hours
Congenital malformation
Concurrent cerebral lesions
ECMO therapy
Contraindication of lactation
Single group
Intranasal breast milk
Biological/VaccineNeonates with hypoxic-ischemic encephalopathy receive their own-mother's fresh breast milk intranasally, starting from the first 48 hours of life and continuing for 28 days. Dose: 2 times daily, 0.4 ml in each nostril (15 minutes apart).
Proportion of patients where treatment was initiated within 48 hours
Feasibility will be based on the ability to initiate treatment within 48 hours of birth using own mother's fresh milk.
Number of adverse events associated with breast milk administration
Number of adverse events associated with breast milk administration will be recorded, including desaturation (SpO2\<80%), bradycardia (heart rate \<70% of baseline), apneic episode requiring bag and mask ventilation within 5 minutes of the intervention, or an increase in respiratory support (mode, setting, or FiO2 increase \>10%) within 1 hour of the intervention.
Time to reach full enteral feeding
Time to reach full enteral feeding will be recorded and analyzed as a secondary outcome.
Length of exclusive breast feeding
Lengths of exclusive breast feeding will be recorded and analyzed as a secondary outcome.
Total number of treatments during first months of life
Total number of treatments administered in hospital and at home during the first months of life
Click on the lead sponsor to view all of their trials.
