Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03613987 |
| Other study ID # |
L12,175 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 26, 2018 |
| Est. completion date |
July 26, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
New York Medical College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Infants delivered weighing less than 1 kg at birth (ELBW) are at high risk for the
development of bronchopulmonary dysplasia (BPD) and Ventilator-Induced Lung Injury (VILI), in
part because of the need for mechanical ventilation utilizing an endotracheal tube (MVET). In
spite of strategies to minimize the need for MVET, the incidence of BPD in ELBW infants
continues to be 20-80%. The hypothesis is that synchronized NIPPV will decrease the need for
MVET and reduce BPD in ELBW infants as compared to NIPPV.
Description:
Hypothesis:
The hypothesis is that sNIPPV will decrease the need for MVET and reduce BPD in ELBW infants
as compared to NIPPV.
Specific Aims:
The specific aims are to determine whether:
1. sNIPPV results in a decreased need for MVET at 7days of life and 28 days of life in ELBW
infants compared to NIPPV.
2. sNIPPV reduces BPD in ELBW infants compared to NIPPV. Research design and methods: ELBW
infants will be enrolled in this study at the RNICU at MFCH of WMC following informed
written parental consent.
Randomization:
ELBW infants will be randomized to either sNIPPV group or NIPPV group using a
computer-generated scheme.
Extubation criteria:
1. Infant is receiving caffeine.
2. Infants can be extubated at any point, but must be extubated following a 12-hour period
of clinical stability when the ventilator settings have met all the following criteria:
- mean airway pressure (MAP) < 8cmH20,
- FiO2 < 0.4,
- pH > 7.2, and
- pCO2 < 70.
Intubation criteria:
Infants must be intubated if any of the following criteria occur:
1. One apneic event requiring positive pressure ventilation (PPV).
2. More than 6 apneic events requiring stimulation within a 6-hour period.
3. A deterioration in respiratory status as noted by any of the following criteria:
- pH < 7.2,
- pCO2 > 70,
- FiO2 > 0.6,
4. Or, if in the opinion of the attending neonatologist, the baby is failing either
non-invasive strategy.
Data Collection:
Demographic and outcome data will be collected from source data, and then the patient will be
given a unique identifier, without reference to MRN or birthdate.
Tracheal aspirates will be collected per routine nursing care to look for inflammatory
cytokine markers (IL8, IL6 and TNF alpha). This may help to determine if certain infants
remained intubated due to a pro-inflammatory mechanism (if their TA cytokines were elevated
early compared to those who may have been more successfully extubated because of low levels
of cytokines).
During hospital stay, DNA and RNA samples will be extracted from buccal swabs, as certain
babies are more susceptible to BPD based on their genetic foundations.
Charts will be reviewed to determine the duration of oxygen therapy as well as the duration
of MVET.
MVET will be assessed at 7 days of life and 28 days of life as primary outcome. BPD, as
defined as oxygen requirement at 36 weeks PMA, is a secondary outcome. Initial statistical
analysis will be performed using chi square for categorical data; and t-test or Mann Whitney
for continuous data that is normally or non-normally distributed (respectively), with
statistical significance when P < 0.05.
Power analysis:
Based on the investigators' NICU data that NIPPV has MVET rate at 7 days of life of 84% for
ELBWs, it was hypothesized that sNIPPV will decrease the need for MVET at 7 days of life by
40%. For a power of 80%, and an alpha value of 0.05, the sample size is 27 infants in each
group. Anticipating a 10% dropout rate, this gives 30 as the sample size for each group.
Anticipated timeline:
With 80-100 ELBW infants admitted each year, enrollment is anticipated to be completed in 1
year.
The clinical implications of this study will determine if synchronized NIPPV in ELBW infants
will reduce the need for mechanical ventilation and ultimately BPD.
There are no procedures, situations, or materials that will be hazardous to personnel. There
are no courses planned which support the research training experience. This research will not
include the use of experimental drugs or treatments.
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