Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/9/2019 |
| Start Date: | December 2015 |
| End Date: | December 2022 |
| Contact: | Colm P Travers, MB BCh BAO |
| Email: | ctravers@peds.uab.edu |
| Phone: | 205 934 4680 |
A Randomized Controlled Trial of pH-Controlled Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants
Preterm infants, less than 37 weeks gestation with respiratory distress syndrome, who remain
ventilated between 7 and 14 days after birth will be randomized to a ventilator strategy of
either a higher level of permissive hypercapnia or of a lower level of permissive hypercapnia
to determine if either strategy will increase the number of alive ventilator-free days in the
28 days after randomization.
ventilated between 7 and 14 days after birth will be randomized to a ventilator strategy of
either a higher level of permissive hypercapnia or of a lower level of permissive hypercapnia
to determine if either strategy will increase the number of alive ventilator-free days in the
28 days after randomization.
22.0 to 36.6 weeks gestational age preterm infants with respiratory distress syndrome, who
remain ventilated between 7 and 14 days after birth will be randomized to one of two
ventilator strategies: 1) a higher level of permissive hypercapnia or 2) a lower level of
permissive hypercapnia to determine if either strategy will increase the number of alive
ventilator-free days in the 28 days after randomization.
After parental consent obtained, intubated, mechanically ventilated infants will be
randomized by use of sequentially numbered sealed opaque envelopes to the treatment
assignment. Randomized infants will be stratified by gestational age at delivery (< 26 weeks,
≥ 26 wks but less than 29 weeks, and ≥ 29 weeks). Multiple births will be randomized to the
same group. The envelope will be opened only on days 7-14 when infant meets criteria.
Clinicians will follow pre-specified algorithms of extubation and reintubation criteria to
wean infants from mechanical ventilation. The ventilation algorithms may be set aside until
the infant is deemed stable enough to allow resumption of the study algorithm.
Infant will be extubated within 24 hours of meeting extubation criteria and documented on a
single blood gas. A trial of extubation per attending physician is allowed independent of the
trial protocol.All other care is per unit standard.
Reports of routine follow-up after discharge in babies < 27 weeks gestation will be obtained
to determine neurodevelopmental impairment on this subset of babies.
remain ventilated between 7 and 14 days after birth will be randomized to one of two
ventilator strategies: 1) a higher level of permissive hypercapnia or 2) a lower level of
permissive hypercapnia to determine if either strategy will increase the number of alive
ventilator-free days in the 28 days after randomization.
After parental consent obtained, intubated, mechanically ventilated infants will be
randomized by use of sequentially numbered sealed opaque envelopes to the treatment
assignment. Randomized infants will be stratified by gestational age at delivery (< 26 weeks,
≥ 26 wks but less than 29 weeks, and ≥ 29 weeks). Multiple births will be randomized to the
same group. The envelope will be opened only on days 7-14 when infant meets criteria.
Clinicians will follow pre-specified algorithms of extubation and reintubation criteria to
wean infants from mechanical ventilation. The ventilation algorithms may be set aside until
the infant is deemed stable enough to allow resumption of the study algorithm.
Infant will be extubated within 24 hours of meeting extubation criteria and documented on a
single blood gas. A trial of extubation per attending physician is allowed independent of the
trial protocol.All other care is per unit standard.
Reports of routine follow-up after discharge in babies < 27 weeks gestation will be obtained
to determine neurodevelopmental impairment on this subset of babies.
Inclusion Criteria:
- Gestational age at least 22 but less than 37 weeks;
- Intubated on mechanical ventilation for respiratory distress syndrome on days 7-14
after birth;
- Admitted to Neonatal Intensive Care Unit before 7 days after birth;
- Informed consent per parent(s)
Exclusion Criteria:
- Major malformation
- Neuromuscular condition that affects respiration
- Terminal illness
- Attending physician has made a decision to withhold or limit support for the infant
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