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New treatment option for Newborn Asphyxia
Official title Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
ClinicalTrials.gov ID: NCT06394453
What this study is testing
- What it's testing
- Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation. Many neonatal units do not use enteral feeding during TH, in fear of increased risk of complications.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 6
You may be able to join if
- 35 weeks or more gestational age
- \< 6 hours post birth
- Any of the following:
- Metabolic or mixed acidosis with a pH of ≤7.0 or a base deficit ≥16 mmol/L in an umbilical cord blood sample or any blood obtained within first hour...
- 10-minute Apgar score of ≤5
You likely can't join if
- Critical general condition
- Aneuploidies (13 th , 18 th , 21 st )
- Birth weight \<1800 g
- Severe congenital defects with poor prognosis
- Severe mechanical head injuries
- Congenital malformations of digestive system (esophageal atresia, duodenal atresia, gastroschisis, omphalocele, anal atresia)
See the full eligibility criteria
- 35 weeks or more gestational age
- \< 6 hours post birth
- Any of the following:
- Metabolic or mixed acidosis with a pH of ≤7.0 or a base deficit ≥16 mmol/L in an umbilical cord blood sample or any blood obtained within first hour after birth
- 10-minute Apgar score of ≤5
- Ongoing resuscitation initiated at birth and continued for ≥10 minutes
- Moderate to severe encephalopathy on clinical examination, using a Thompson HIE score ≥ 7
- Signed informed consent by parent
- Critical general condition
- Aneuploidies (13 th , 18 th , 21 st )
- Birth weight \<1800 g
- Severe congenital defects with poor prognosis
- Severe mechanical head injuries
- Congenital malformations of digestive system (esophageal atresia, duodenal atresia, gastroschisis, omphalocele, anal atresia)
The study team makes the final eligibility decision.
Where it's taking place
- Cracow, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 6 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cracow, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.