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Respiratory InsufficiencyPhase 1NCT02499744

Humidified High Flow Nasal Cannula Versus Nasal Intermittent Positive Ventilation in Neonates

A Phase 1 study testing NIPPV and HHFNC in people with Respiratory Insufficiency, run by Gao WeiWei.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators hypothesize that the Humidified High Flow Nasal Cannula(HHFNC) is effective and safe as primary respiratory support in neonate with respiratory distress syndrome(RDS). It is more convenient in HHFNC combined with kangaroo care. Read more about this study

Who is it for?
Ages Up to 28 days
Conditions the study is for
Respiratory Insufficiency
What is being tested?
NIPPV and HHFNC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
Feb 2016to May 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Birth weight > 1000 grams and > 28 weeks gestation
  • have respiratory distress syndrome and need assistant ventilation

Who cannot join

  • Birth weight < 1000 grams
  • Estimated gestation < 28 weeks
  • infants have contraindications for use of non-invasive ventilation
  • Active air leak syndrome
  • Infants with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis, cleft lip and/or palate, or
  • Infants with significant abdominal or respiratory malformations including trachea-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia.

About this study

Official title: Humidified High Flow Nasal Cannula Versus Nasal Intermittent Positive Ventilation in Neonates as Primary Respiratory Support:a Randomized Controlled Trial

The investigators hypothesize that the Humidified High Flow Nasal Cannula(HHFNC) is effective and safe as primary respiratory support in neonate with respiratory distress syndrome(RDS). It is more convenient in HHFNC combined with kangaroo care.

Read the detailed description

Today a new nursing principle proposed that is kangaroo care in neonate.Many study showed kangaroo care may reduce pain、decrease the respiratory and heart rate among preterm infant.The recently study show it benefit to Physical Growth and Neurodevelopment.

Respiratory failure remains a common problem in the neonatal intensive unit. As reported that early non-invasive ventilation is accompanied by significant improvement in subsequent lung development and alveolation.Nasal continuous positive airway pressure (NCPAP)、nasal intermittent positive pressure ventilation(NIPPV) and humidified high flow via nasal cannulas(HHFNC) are non-invasive ventilation models.But Unfortunately, NIPPV and NCPAP systems are not always easily applied or tolerated in the preterm infants.So it is not convenient in kangaroo care.Recently A meta analysis concluded that NIPPV is more effective than NCPAP in preterms respiratory diseases.Maybe the investigators can reason that NIPPV is effective than HHFNC,but there is limited data about the comparison of NIPPV and HHFNC as primary respiratory support in neonate.

The NIPPV group fail definition：1、FiO2>40%、MAP>10 centimeter water column (cm H2O),but SaO2<90%.2、significant abdominal distension.3、PaCO2>60 millimeter of mercury (mmHg)or partial pressure of arterial oxygen (PaO2)<45mmHg.4、severe apnea( definition:>6 episodes requiring stimulation in 6 hours or requiring >1 episodes of positive-pressure ventilation) 5.potential of hydrogen (PH)<7.2 The HHFNC group fail definition：1、FiO2>40%、flow>8 (litre,L)/min,but SaO2<90%.2、significant abdominal distension.3、PaCO2>60mmHg or PaO2<45mmHg.4、severe apnea 5.PH<7.2

Being tested
NIPPV, HHFNC
Keywords
NIPPV, HHFNC, RDS, neonate
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIPPVDevice

    Also called nasal intermittent postive pressure ventilaiton

    For infants in the NIPPV-group who "fail"NIPPV (see definition below), need immediate intubation, a invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.

  • HHFNCDevice

    Also called Humidified High Flow Nasal Cannula

    For infants in the HHFNC-group who "fail"HHFNC (see definition below), need immediate intubation, a invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.

Study groups in NCT02499744
Study groupRoleWhat they receive
HHFNCActive comparatorHHFNC is provided nasal cannula. Ventilator settings:fraction of inspired oxygen (FiO2):21-40%,flow:2-8(litre,L)/min,to maintain arterial blood hemoglobin oxygen saturation ( SaO2) at 90-95% The weaning process is left to the discretion of the attending physician.,when FiO2: 25%,flow:2(litre,L)/min.
Receives: Device: HHFNC
NIPPVActive comparatorNIPPV is provided via binasal prongs. Ventilator settings:FiO2:21-40%,peak inspiratory pressure( PIP)：12-22cm H2O,positive and expiratory pressure(PEEP):5-7cm H2O,Rate:30-60 per minute to maintain SaO2 at 90-95%,The weaning process is left to the discretion of the attending physician,when FiO2: 25%,mean airway pressure (MAP):6cm H2O,R:30 per minute .
Receives: Device: NIPPV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. endotracheal intubation rate

    endotracheal intubation rate assessed within 72 hours after extubation

    Measured: 3 days

Secondary outcomes (7)

  1. significant apnea

    significant apnea measured by the Colin J definition:6 episodes requiring stimulation in 6 hours or requiring>1 episodes of positive -pressure ventilation

    Measured: 7 days

  2. duration of non-invasive ventilation

    the duration of ventilation measured by total non-invasive ventilation time in HHFNC and NIPPV groups

    Measured: 3 months

  3. air leaks

    air leak assessed by chest X-ray

    Measured: 3 months

  4. full enteral feeding

    full enteral feeding measured by total feeding dose above 120 ml per kilogram one day

    Measured: 3 months

  5. Bronchopulmonary dysplasia

    Bronchopulmonary dysplasia assessed by national institute of child health and human development(NICHD) definition

    Measured: 3 months

  6. necrotizing enterocolitis

    necrotizing enterocolitis assessed by abdominal X-ray and Bell classification

    Measured: 3 months

  7. nasal trauma

    nasal trauma measured by US national pressure Ulcer Advisory Panel(NPUAP)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionMay 2017 (estimated)
  4. Study completionMay 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02499744
Sponsor's protocol ID
GuangdongWCHHI
Status last verified
Feb 2016
First submitted
24 May 2015
Last updated
24 Feb 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Chidambaram AG, Manjula S, Adhisivam B, Bhat BV. Effect of Kangaroo mother care in reducing pain due to heel prick among preterm neonates: a crossover trial. J Matern Fetal Neonatal Med. 2014 Mar;27(5):488-90. doi: 10.3109/14767058.2013.818974. Epub 2013 Jul 18.

    PubMed 23796239

  • Gathwala G, Singh B, Singh J. Effect of Kangaroo Mother Care on physical growth, breastfeeding and its acceptability. Trop Doct. 2010 Oct;40(4):199-202. doi: 10.1258/td.2010.090513. Epub 2010 Jul 28.

    PubMed 20667921

  • Padhi TR, Sareen D, Pradhan L, Jalali S, Sutar S, Das T, Modi RR, Behera UC. Evaluation of retinopathy of prematurity screening in reverse Kangaroo Mother Care: a pilot study. Eye (Lond). 2015 Apr;29(4):505-8. doi: 10.1038/eye.2014.340. Epub 2015 Jan 23.

    PubMed 25613847

  • Head LM. The effect of kangaroo care on neurodevelopmental outcomes in preterm infants. J Perinat Neonatal Nurs. 2014 Oct-Dec;28(4):290-9; quiz E3-4. doi: 10.1097/JPN.0000000000000062.

    PubMed 25347107

  • Thomson MA, Yoder BA, Winter VT, Martin H, Catland D, Siler-Khodr TM, Coalson JJ. Treatment of immature baboons for 28 days with early nasal continuous positive airway pressure. Am J Respir Crit Care Med. 2004 May 1;169(9):1054-62. doi: 10.1164/rccm.200309-1276OC. Epub 2004 Feb 12.

    PubMed 14962819

  • 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.

    PubMed 17262040

  • Davis PG, Lemyre B, de Paoli AG. Nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (NCPAP) for preterm neonates after extubation. Cochrane Database Syst Rev. 2001;(3):CD003212. doi: 10.1002/14651858.CD003212.

    PubMed 11687052

  • 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.

    PubMed 16724119

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NIPPV and HHFNC in people with Respiratory Insufficiency, run by Gao WeiWei.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

endotracheal intubation rate (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02499744, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.

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