Using Nasal High Flow From Birth in Premature Infants - a Pilot Study

NCT01991886 | Completed

• 2 other identifiers: 2013PR01131594
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Recent large studies have shown that not all premature babies need to be intubated (have a breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant routinely. Those studies showed that even very small babies can be safely supported using nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to breath, albeit with additional support to reduce their work of breathing. However nCPAP has some drawbacks, including that it can cause skin damage to the nose, and that the heating and humidification of the gas is not always sufficient. We have been using, for over 5 years, a different system to support babies after routine intubation. This is another type of noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm Precision Flow device. Published trials show that it is at least as effective as nCPAP to provide NIV and to prevent the subsequent need for intubation and/or surfactant. However nHF is superior to nCPAP in respect it does not cause nose damage and its heating and humidification is excellent. This pilot study aims to describe and evaluate the use of nHF, using a standard commercially available system (Precision Flow, Vapotherm Inc.), from birth, in babies born less than 30 completed weeks gestation, with a view to avoiding intubation and ventilation. This study is important to establish the feasibility of using nHF immediately after birth.

Conditions

Premature Birth

Keywords

nasal High Flow; premature baby; CPAP (Continuous positive airways pressure)

Outcome Measures

Primary Outcomes (1)

• Need for endotracheal intubation prior to admission to Neonatal Unit

  Babies who are clinically stable will not require intubation prior to admission to the neonatal unit.

  From birth

Secondary Outcomes (3)

• Development of pneumothorax within 24 hours of birth

  First 24 hours after birth

• Requirement for endotracheal intubation and surfactant administration after admission to neonatal unit within 24 hours of birth

  First 24 hours after admission to neonatal unit

• Development of bronchopulmonary dysplasia defined as oxygen requirement at 36 weeks corrected age

  Defined at 36 weeks corrected age

Study Arms (1)

nasal High Flow applied

EXPERIMENTAL

Application of nasal High Flow 6-7l/min via nasal prongs after birth using a mobile Vapotherm Precision Flow device

Device: Vapotherm Precision Flow

Interventions

Vapotherm Precision Flow DEVICE

Application of nasal High Flow using 6-7 l/min delivered by nasal prongs from birth

Also known as: nasal High Flow device, nasal heated humidified high flow cannula

nasal High Flow applied

Eligibility Criteria

• Age: 24 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parental consent
• +0 to 30+0 weeks(agreed dates) gestation born alive
• Breathing spontaneously at birth or soon after with minimal resuscitation
• Oxygen saturations \>90% by 5 minutes

You may not qualify if:

• No parental consent
• Born in poor condition and unlikely to survive
• Needing resuscitation including intubation and/or chest compressions
• Not breathing and thus needing intubation
• Oxygen saturations \<90% by 5 minutes
• \<24 weeks gestation
• \>30 weeks gestation

Sponsors & Collaborators

• Ashford and St. Peter's Hospitals NHS Trust: lead

Study Sites (1)

Neonatal ICU, St Peter's Hospital

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Related Publications (1)

• Reynolds P, Leontiadi S, Lawson T, Otunla T, Ejiwumi O, Holland N. Stabilisation of premature infants in the delivery room with nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F284-7. doi: 10.1136/archdischild-2015-309442. Epub 2016 Jan 5.

  PMID: 26733541 DERIVED

MeSH Terms

Conditions

Premature Birth; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Peter Dr Reynolds, PhD

  Ashford and St. Peter's Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 12, 2016

Record last verified: 2016-08

Locations

GB (1)