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

Respiratory Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02499744
• Other study ID #: GuangdongWCHHI
• Status: Active, not recruiting
• Phase: Phase 1
• First received: May 24, 2015
• Last updated: February 22, 2016
• Start date: February 2016
• Est. completion date: May 2017

Study information

• Verified date: February 2016
• Source: Guangdong Women and Children's Hospital and Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

1. Birth weight > 1000 grams and > 28 weeks gestation

2. have respiratory distress syndrome and need assistant ventilation

Exclusion Criteria:

1. Birth weight < 1000 grams

2. Estimated gestation < 28 weeks

3. infants have contraindications for use of non-invasive ventilation

4. Active air leak syndrome

5. 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

6. Infants with significant abdominal or respiratory malformations including trachea-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• NIPPV
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.
• HHFNC
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gao WeiWei

References & Publications (8)

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2014;9:CD003212. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Feb 12. — View Citation

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. Epub 2006 May 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pain score	pain score assessed by neonatal infant pain scale (NIPS)	3 months	Yes
Other	neurodevelopment	neurodevelopment assessed by Bayley scale	3 months	Yes
Primary	endotracheal intubation rate	endotracheal intubation rate assessed within 72 hours after extubation	3 days	No
Secondary	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	7 days	Yes
Secondary	duration of non-invasive ventilation	the duration of ventilation measured by total non-invasive ventilation time in HHFNC and NIPPV groups	3 months	Yes
Secondary	air leaks	air leak assessed by chest X-ray	3 months	Yes
Secondary	full enteral feeding	full enteral feeding measured by total feeding dose above 120 ml per kilogram one day	3 months	Yes
Secondary	Bronchopulmonary dysplasia	Bronchopulmonary dysplasia assessed by national institute of child health and human development(NICHD) definition	3 months	Yes
Secondary	necrotizing enterocolitis	necrotizing enterocolitis assessed by abdominal X-ray and Bell classification	3 months	Yes
Secondary	nasal trauma	nasal trauma measured by US national pressure Ulcer Advisory Panel(NPUAP)	3 months	Yes