Neonatal Respiratory Distress Syndrome Clinical Trial
— FLIPIOfficial title:
Flow-cycled Ventilation in Preterm Infants (FLIPI): A Pilot Study Looking at the Tolerance of Flow-cycled Ventilation by Preterm Infants With Respiratory Distress Syndrome
NCT number | NCT02522455 |
Other study ID # | R04003 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | October 2016 |
Verified date | November 2018 |
Source | Manchester University NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This short pilot study is to assess the tolerance of preterm infants, born below 32 weeks
gestation with respiratory distress syndrome, to flow-cycle ventilation, and see if infants
require less overall pressure from the ventilator than the usual conventional settings used,
with the aim of providing data to construct a larger trial looking at the longer term outcome
of these infants using this type of ventilation in the future.
Many preterm infants at these gestations require assistance from a ventilator due to the
immaturity of their lungs. The lungs of preterm infants are susceptible to damage, especially
if high pressures are needed or prolonged periods of ventilation. There is concern that if
the infant's breathing pattern does not synchronise with the ventilator, this causes
additional distress, longer duration of ventilation needed and increased risk of
complications. Over the past 20 years, a different type of ventilation, known as flow-cycle
ventilation, has been trialed, with limited use in preterm infants. This allows the baby to
determine the duration of breathing in and out and how many breaths they require per minute.
This would help babies to synchronise better with the ventilator, and consequently require
less pressure from the ventilator.
This pilot study is being conducted at St. Mary's Hospital, Manchester. All babies born under
32 weeks gestation, with a stable respiratory effort, will be eligible for consideration for
the study. The study will last no longer than 5 hours and involve the babies receiving
different pressures from the ventilator in flow-cycle mode for 1-hour epochs. Blood gases
after each epoch and continuous ventilator data will be downloaded to assess their tolerance
on the different settings, before being returned to the usual conventional settings used on
the unit. The babies will have continuous monitoring throughout as per standard neonatal
intensive care.
Status | Completed |
Enrollment | 6 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 24 Hours |
Eligibility |
Inclusion Criteria: - Patients under 32 weeks gestation at time of study enrolment - Evidence of Respiratory Distress Syndrome (Clinical signs of respiratory distress, need for surfactant / ventilation, any O2 requirement with typical Chest radiograph appearance) - Patients to have received loading dose of caffeine, as per unit policy - Informed parental consent given - Intubated and requiring continuing ventilatory support - Exogenous surfactant given if indicated (6 hours or more before study entry) - Cardiovascular status stable for at least 3 hours before study - Stable on ventilation with satisfactory blood gases & inspired oxygen concentration < 40% at time of starting study, and for the preceding 3 hours - Regular spontaneous respiratory effort, consistently triggering the ventilator in SIMV mode, for at least 3 hours prior to the start of the study - Less than 24 hours of age at the start of the study Exclusion Criteria: - Refusal or withdrawal of parental consent - Major congenital abnormality, including any need for surgery - Known large intracranial haemorrhage (grade 3 or 4 intraventricular haemorrhage or other significant intracranial abnormality) - Seizures - Pneumothorax or pulmonary interstitial emphysema - Inspired oxygen requirement > 40% after surfactant administration |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St. Mary's Hospital | Manchester |
Lead Sponsor | Collaborator |
---|---|
Manchester University NHS Foundation Trust | University of Leeds |
United Kingdom,
Abd El-Moneim ES, Fuerste HO, Krueger M, Elmagd AA, Brandis M, Schulte-Moenting J, Hentschel R. Pressure support ventilation combined with volume guarantee versus synchronized intermittent mandatory ventilation: a pilot crossover trial in premature infants in their weaning phase. Pediatr Crit Care Med. 2005 May;6(3):286-92. — View Citation
Attar MA, Donn SM. Mechanisms of ventilator-induced lung injury in premature infants. Semin Neonatol. 2002 Oct;7(5):353-60. Review. — View Citation
De Luca D, Conti G, Piastra M, Paolillo PM. Flow-cycled versus time-cycled sIPPV in preterm babies with RDS: a breath-to-breath randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2009 Nov;94(6):F397-401. doi: 10.1136/adc.2009.162446. Epub 2009 Jul 1. — View Citation
Donn SM, Sinha SK. Minimising ventilator induced lung injury in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F226-30. Review. — View Citation
Gupta S, Sinha SK, Donn SM. The effect of two levels of pressure support ventilation on tidal volume delivery and minute ventilation in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2009 Mar;94(2):F80-3. doi: 10.1136/adc.2007.123679. Epub 2008 Aug 1. — View Citation
Jarreau PH, Moriette G, Mussat P, Mariette C, Mohanna A, Harf A, Lorino H. Patient-triggered ventilation decreases the work of breathing in neonates. Am J Respir Crit Care Med. 1996 Mar;153(3):1176-81. — View Citation
Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. — View Citation
Kapasi M, Fujino Y, Kirmse M, Catlin EA, Kacmarek RM. Effort and work of breathing in neonates during assisted patient-triggered ventilation. Pediatr Crit Care Med. 2001 Jan;2(1):9-16. — View Citation
Osorio W, Claure N, D'Ugard C, Athavale K, Bancalari E. Effects of pressure support during an acute reduction of synchronized intermittent mandatory ventilation in preterm infants. J Perinatol. 2005 Jun;25(6):412-6. — View Citation
Schmalisch G, Wilitzki S, Wauer RR. Differences in tidal breathing between infants with chronic lung diseases and healthy controls. BMC Pediatr. 2005 Sep 8;5:36. — View Citation
Schulzke SM, Pillow J, Ewald B, Patole SK. Flow-cycled versus time-cycled synchronized ventilation for neonates. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD008246. doi: 10.1002/14651858.CD008246.pub2. Review. — View Citation
Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rapid shallow breathing index | Measure of respiratory effort required by infant: calculated by respiratory rate divided by exhaled tidal volume | 6 hours | |
Primary | Mean airway pressure used | Amount of pressure required in either ventilation mode | 6 hours | |
Primary | Inspiratory time | Amount of time the infant require inspiratory support from the ventilator (in flow-cycle mode only) | 6 hours | |
Primary | Respiratory rate | Spontaneous respiratory rate from infant in either ventilation mode | 6 hours | |
Secondary | Exhaled tidal volume | Amount of gas exhaled (measured in mls, ml/kg body weight) | 6 hours | |
Secondary | Exhaled minute ventilation | Product of exhaled tidal volume and respiratory rate | 6 hours | |
Secondary | Oxygen requirement | 6 hours | ||
Secondary | Acid - base balance | Assessment of pH and carbon dioxide clearance in each ventilation mode | In each 1-hour epoch (end of) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04019886 -
Impact of Neurophysiological Facilitation of Respiration in Preterm Neonates
|
N/A | |
Terminated |
NCT02999165 -
Breastfeeding Infants Receiving Respiratory Support Trial
|
||
Completed |
NCT02112513 -
The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome
|
||
Completed |
NCT02824497 -
Early Neonatal Respiratory Distress: Changes in Level IIb Hospital Over a Period of One Year
|
||
Completed |
NCT04000568 -
Breathing Variability and NAVA in Neonates
|
||
Completed |
NCT01926106 -
Nasal Intermittent Positive-Pressure Ventilation for Twin Infants With Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT02819050 -
Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants
|
N/A | |
Completed |
NCT02041676 -
Chest Physiotherapy Technique Increasing Inspiratory Flow on Weaning From Non Invasive Ventilation
|
N/A | |
Completed |
NCT02333669 -
Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome
|
N/A | |
Recruiting |
NCT04409665 -
The Use of Sedation Drugs in the Procedure of Administering Surfactant Without Intubation (LISA/MIST)
|
Phase 1 | |
Completed |
NCT03446937 -
Effect of Antenatal Corticosteroids on Neonatal Morbidity.
|
N/A | |
Terminated |
NCT03235986 -
A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)
|
Phase 2 | |
Recruiting |
NCT06367881 -
Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS
|
Phase 1 |