An Early Phase 1 interventional study of Intranasal breast milk in Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy and Perinatal Asphyxia, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged Up to 48 Hours. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Semmelweis University · Early Phase 1, Interventional, and Treatment
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This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.
Perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (HIE) are the leading cause of neonatal mortality and long-term neurodevelopmental disabilities. Based on our current knowledge, therapeutic hypothermia is the only therapy that has been proven to reduce central nervous system damage in HIE neonates. Improving neurodevelopmental outcomes of newborns with HIE has been an intense area of research over the past decade.
Breast milk is a complex biological substance that contains a variety of bioactive components including neurotrophic growth factors, cytokines, immunoglobulins, and multipotent stem cells. Studies have shown that exclusive breastfeeding in the early stages of development has a positive impact on cognitive outcomes. Animal studies support that mesenchymal stem cells and neurotrophic substances found in breast milk, when administered intranasally enter the central nervous system and reduce the extent of neurological damage. In preterm infants, it has been shown that intranasally administered breast milk is safe and well-tolerated.
In this open-label prospective randomized controlled single-center interventional study, the objective is to administer fresh, own-mother's breast milk intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days.
The primary objective is to compare neurodevelopmental outcomes between the control group and the intervention group receiving intranasal breast milk treatment. The secondary objective is to compare the progression of enteral feeding and the duration of exclusive breastfeeding between the intervention and the control group.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
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Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia
≥ 35. gestational week \< 48 hours of life
Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard care for moderate or severe hypoxic-ischemic encephalopathy with hypothermia.
Fresh own mother's breast milk expressed within 4 hours, will be administered 2 times daily, 0.4 ml in each nostril for 28 days.
Biological: Intranasal breast milk
Own-mother's fresh breast milk (within 4 hours of having been expressed), is administered intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days. Dose: 2 times daily, 0.4 ml in each nostril.
Neurodevelopmental outcome
The primary outcome will be the 2 year neurodevelopmental outcome comparing standard care and intranasal breast milk therapy groups. The Bayley Scales of Infant Development, Third Edition (Bayley-III) score will be used to assess neurodevelopmental outcome, favorable outcome is defined as having composite scores for cognitive, language and motor scales \>85, while adverse outcome is defined as composite scores \<80 or death.
Time frame: 2 years
Time to reach full enteral feeding
Time to reach full enteral feeding will be recorded and analyzed as a secondary outcome.
Time frame: 1 month
Length of exclusive breast feeding
Lengths of exclusive breast feeding will be recorded and analyzed as a secondary outcome.
Time frame: 2 years
Plan to share: Yes — On special request pending data transfer agreement approval by Semmelweis University.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 20.12.2024.-01.01.2030.
Access criteria: On special request pending data transfer agreement approval by Semmelweis University. Sharing upon reasonable request.
Data sharing details ↗ · semmelweis.hu
Start is estimated for Feb 2025; primary completion for Jan 2028, 35 months later.
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