NCT03171129

Brief Summary

This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
9.1 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

May 25, 2017

Last Update Submit

January 28, 2026

Conditions

Respiratory Distress Neonatal

Keywords

Respiratory DistressNasal CPAPhigh flow nasal canula

Outcome Measures

Primary Outcomes (1)

  • Duration of Oxygen Use

    The length of time the patient is on oxygen will be measured in hours.

    From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days.

Secondary Outcomes (3)

  • Oxygen Concentration

    From time of randomization until time of discharge from NICU up to 100 days.

  • Number of Participants with treatment-related pneumothorax

    From time of randomization until time of discharge from NICU up to 100 days.

  • Number of Participants with Excoriation at Nasal Site

    From time of randomization until time of discharge from NICU up to 100 days.

Study Arms (2)

High flow nasal cannula system w/ ADINA

EXPERIMENTAL

The intervention is the insertion of the the ADINA device into the high flow nasal cannula system. ADINA will be placed according to weight class recommendations to increase the positive end expiratory pressure (PEEP). ADINA is actually a combination of the Neotech RAM Cannula and a clear Regulator/Pop off valve.

Device: Adaptive Dynamic Inspiratory Nasal Apparatus

high flow nasal cannula system

ACTIVE COMPARATOR

High flow nasal cannula will deliver oxygen at 2-4 lpm of flow. High flow cannula are used to provide the control interface.

Device: High flow Nasal Canula

Interventions

Adaptive Dynamic Inspiratory Nasal ApparatusDEVICE

Oxygen will be administered via ADINA

Also known as: ADINA
High flow nasal cannula system w/ ADINA
High flow Nasal CanulaDEVICE

Oxygen will be administered via nasal canula

high flow nasal cannula system

Eligibility Criteria

Age23 Weeks - 40 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonates admitted to NICU
  • Weights of 400-500 grams
  • Requiring oxygen greater than 30%
  • No evidence of focal lobar consolidation in lung fields

You may not qualify if:

  • Intolerance to procedure
  • gelatinous skin
  • known allergy to adhesive material
  • interference with therapy
  • profound sepsis
  • pneumonia
  • unmanaged apnea/bradycardia
  • known or suspect complex congenital heart disease
  • severe cleft lip or palate
  • suspect or proven lethal congenital anomaly
  • intolerance to the interface used in the devices
  • inability to secure an appropriate fit of the patient nasal interface
  • considered non-viable or of uncertain viability
  • parental refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Related Publications (9)

  • Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. doi: 10.1056/NEJM197106172842401. No abstract available.

    PMID: 4930602BACKGROUND

  • Dutta S. High-flow nasal cannula versus nasal continuous positive airway pressure in the management of apnea of prematurity. Pediatrics. 2002 Apr;109(4):718-9; author reply 718-9. doi: 10.1542/peds.109.4.718. No abstract available.

    PMID: 11927724BACKGROUND

  • Campbell DM, Shah PS, Shah V, Kelly EN. Nasal continuous positive airway pressure from high flow cannula versus Infant Flow for Preterm infants. J Perinatol. 2006 Sep;26(9):546-9. doi: 10.1038/sj.jp.7211561. Epub 2006 Jul 13.

    PMID: 16837929BACKGROUND

  • Kubicka ZJ, Limauro J, Darnall RA. Heated, humidified high-flow nasal cannula therapy: yet another way to deliver continuous positive airway pressure? Pediatrics. 2008 Jan;121(1):82-8. doi: 10.1542/peds.2007-0957.

    PMID: 18166560BACKGROUND

  • Woodhead DD, Lambert DK, Clark JM, Christensen RD. Comparing two methods of delivering high-flow gas therapy by nasal cannula following endotracheal extubation: a prospective, randomized, masked, crossover trial. J Perinatol. 2006 Aug;26(8):481-5. doi: 10.1038/sj.jp.7211543. Epub 2006 May 25.

    PMID: 16724119BACKGROUND

  • Shoemaker MT, Pierce MR, Yoder BA, DiGeronimo RJ. High flow nasal cannula versus nasal CPAP for neonatal respiratory disease: a retrospective study. J Perinatol. 2007 Feb;27(2):85-91. doi: 10.1038/sj.jp.7211647.

    PMID: 17262040BACKGROUND

  • Sreenan C, Lemke RP, Hudson-Mason A, Osiovich H. High-flow nasal cannulae in the management of apnea of prematurity: a comparison with conventional nasal continuous positive airway pressure. Pediatrics. 2001 May;107(5):1081-3. doi: 10.1542/peds.107.5.1081.

    PMID: 11331690BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Update: Ralstonia species associated with Vapotherm oxygen delivery devices--United States, 2005. MMWR Morb Mortal Wkly Rep. 2005 Nov 4;54(43):1104-5.

    PMID: 16267498BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Ralstonia associated with Vapotherm oxygen delivery device--United States, 2005. MMWR Morb Mortal Wkly Rep. 2005 Oct 21;54(41):1052-3.

    PMID: 16237377BACKGROUND

MeSH Terms

Conditions

Hyaline Membrane DiseaseDyspnea

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, NewbornRespiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mitchell R Goldstein, MD

    Loma Linda University Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tina Ramirez

CONTACT

909-558-5828TIRameriz@llu.edu

Alyssa Taber

CONTACT

909-558-6087ATaber@llu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 31, 2017

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)