Clinical trial NCT02499744: Humidified High Flow Nasal Cannula Versus Nasal Intermittent Positive Ventilation in Neonates
Official title: Humidified High Flow Nasal Cannula Versus Nasal Intermittent Positive Ventilation in Neonates as Primary Respiratory Support:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Respiratory Insufficiency
Keywords: NIPPV
HHFNC
RDS
neonate
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 200
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: endotracheal intubation rate
timeFrame: 3 days
Secondary outcomes:
measure: significant apnea
timeFrame: 7 days
measure: duration of non-invasive ventilation
timeFrame: 3 months
measure: air leaks
timeFrame: 3 months
measure: full enteral feeding
timeFrame: 3 months
measure: Bronchopulmonary dysplasia
timeFrame: 3 months
measure: necrotizing enterocolitis
timeFrame: 3 months
measure: nasal trauma
timeFrame: 3 months
Other outcomes:
measure: pain score
timeFrame: 3 months
measure: neurodevelopment
timeFrame: 3 months
Locations:
Study officials:
affiliation: Guangdong Women and Children Hospital
name: yang jie, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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. doi: 10.1164/rccm.200309-1276OC. Epub 2004 Feb 12.
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. doi: 10.1038/sj.jp.7211647.
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. doi: 10.1002/14651858.CD003212.
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. doi: 10.1038/sj.jp.7211543. Epub 2006 May 25.