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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HHFNC | Active Comparator | HHFNC 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. |
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| NIPPV | Active Comparator | NIPPV 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 . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIPPV | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| endotracheal intubation rate | endotracheal intubation rate assessed within 72 hours after extubation | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| duration of non-invasive ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| pain score | pain score assessed by neonatal infant pain scale (NIPS) | 3 months |
| neurodevelopment | neurodevelopment assessed by Bayley scale | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yang jie, doctor | Guangdong Women and Children Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23796239 | Background | 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. | |
| 20667921 | Background | 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. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| HHFNC | Device | 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. |
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the duration of ventilation measured by total non-invasive ventilation time in HHFNC and NIPPV groups
| 3 months |
| air leaks | air leak assessed by chest X-ray | 3 months |
| full enteral feeding | full enteral feeding measured by total feeding dose above 120 ml per kilogram one day | 3 months |
| Bronchopulmonary dysplasia | Bronchopulmonary dysplasia assessed by national institute of child health and human development(NICHD) definition | 3 months |
| necrotizing enterocolitis | necrotizing enterocolitis assessed by abdominal X-ray and Bell classification | 3 months |
| nasal trauma | nasal trauma measured by US national pressure Ulcer Advisory Panel(NPUAP) | 3 months |
| 25613847 | Background | 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. |
| 25347107 | Background | 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. |
| 14962819 | Background | 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. |
| 17262040 | Background | 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. |
| 11687052 | Background | 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. |
| 16724119 | Background | 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. |