Does the use of NIPPV in ELBW infants (
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
composite primary outcome is BPD-free-survival. The oxygen reduction test is
used to assess BPD.
Secondary outcome
Secondary outcomes are mortality at 36 weeks, BPD at 36 weeks, other
respiratory parameters, and complications of prematurity such as NEC, ROP, IVH,
infections. Cost-effectiveness analyses.
Background summary
BPD is one of the leading causes of mortality and morbidity in ELWB infants.
BPD is directly related to ventilator induced lung injury. Clinicians strive to
minimize ventilator induced injury by exploring alternative non-invasive
respiratory support. One important potential effective strategy is nasal
intermittent positive pressure ventilation (NIPPV). Efficacy and safety of
NIPPV versus standard care with continuous positive airway pressure CPAP have
not been sufficiently explored yet.
Study objective
Does the use of NIPPV in ELBW infants (<30 wks of GA and BW<1000gr) requiring
non-intubated respiratory support in a Level III perinatal center increase the
rate of survival without BPD when compared to nCPAP.
Study design
Multicenter, international, randomised controlled, parallel, two arm trial with
open label and blinded outcome assessment.
Intervention
Participating infants treated with the intention to manage the infant with
non-invasive respiratory support (day 0-7) ór after extubation (day 1-28) will
be randomised to non-invasive respiratory support using nasal NIPPV (study
group) or nasal CPAP (control group).
Study burden and risks
Infants requiring any form of respiratory support are, by definition, requiring
intensive care. Standard pressure support with nCPAP has known associated side
effects: pulmonary air leaks, perforated abdominal viscera, nasal deformities
and feed intolerance. We anticipate that NIPPV will carry the same complication
risks. Participation to the trial does not require additional examinations or
blood withdrawals, other than the oxygen reduction test (Walsh) to assess BPD.
Infants randomized to the NIPPV group may have the advantage of prevention of
(re)-intubation and mechanical ventilation, while CPAP alone may have failed if
they were allocated to the CPAP group. On the other hand, infants randomized to
the CPAP group could have the advantage of less respiratory support, that is no
nasal intermittent ventilation, and more progressive weaning if CPAP alone
would have been sufficient.
Hanzeplein 1
9700 RB Groningen
Nederland
Hanzeplein 1
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Gestational age less than 30 weeks
Birthweight less than 1 kg
Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube) whether
A. primairy: within the first 7 days of life and the infant has never been intubated or has received less than 24 hours of intubated respiratory support (e.g. for endotracheal surfactant therapy /INSURE:intubate-surfactant replacement therapy-extubate)
OR
B. secondary:the infant is within the first 28 days of life, has been managed with intubated respiratory support for more than 24 hours and is a candidate for extubation followed by non-invasive respiratory support.
Exclusion criteria
1. Considered Non-viable by attending physician
2. Life-threatening congenital abnormalties including congenital heart disease (exl patent ductus arteriosus)
3. Infants known to require surgical treatmene e.g. congenital diaphragmatic hernia, tracheo-oesophageal fistula, omphalocele and gastroschisis.
4. Abnormalties of the upper and lower airways; such as Pierre-Robin sequence, Treacher Collins syndrome, Goldenhar syndrome, cleft lips and palate.
5. Neuromuscular disorders.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ISRTCN 15233270 |
| CCMO | NL24512.042.08 |