| Gupta et al. (2020)1818 Gupta B.K., Saha A.K., Mukherjee S., Saha B. Minimally invasive surfactant therapy versus InSurE in preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation-a randomized controlled trial. Eur J Pediatr. 2020;179:1287-93.
|
58 (29/29) |
Insertion of a probe by direct laryngoscopy using forceps. After placement of the probe, the laryngoscope was removed. |
The neonates were intubated for surfactant replacement therapy, on positive pressure ventilation and a self-inflating resuscitation bag. Neonates were extubated immediately after surfactant administration and placed back on NIPPV. |
Need for IMV in the first 72 h of life. |
Need for IMV in 72h:
There was no statistically significant difference between the LISA group (10.34%) and the INSURE group (20.69%).
Persistence of the ductus arteriosus,
PIVH > grade 2, BPD and BPD outcome/pre-discharge mortality: No differences were observed between the two groups.
Hospital stay:
Neonates in the INSURE group stayed in the hospital longer than in the LISA group (mean 41.6 days vs 29.76 days).
Need for a second dose of surfactant: There was no difference. |
| Mirnia et al. (2013)1313 Mirnia K., Heidarzadeh M., Hosseini M.B., Sadeghnia A., Balila M., Ghojazadeh M. Comparison outcome of surfactant administration via tracheal catheterization during spontaneous breathing with insure. Med J Islam World Acad Sci. 2013;21:143-8.
|
80 (38/42) |
Tracheal instillation via catheter during spontaneous breathing under nCPAP. |
The neonates were intubated, received positive pressure ventilation for 30 s while surfactant was administered. After surfactant instillation, they were placed on nCPAP immediately.
|
-
|
Duration of ventilation:
There was no difference between the duration of mechanical ventilation between the two groups (p < 0.2), but the mean total duration of CPAP was shorter in the LISA group, in contrast to the INSURE group (p < 0.01).
Morbidities:
There was no difference in the prevalence of BPD, patent ductus arteriosus, PIVH, pneumothorax, sepsis and retinopathy of prematurity between the two groups.
O2 supplement need and length of stay: Lower rates in the LISA group compared to the INSURE group, but not statistically significant. |
| Jena et al. (2019)1919 Jena S.R., Bains H.S., Pandita A., Verma A., Gupta V., Kallem V.R., et al. Surfactant therapy in premature babies: SurE or InSurE. Pediatr Pulmonol. 2019;54:1747-52.
|
350 (175/175) |
Direct laryngoscopy was performed and the catheter or feeding tube was inserted through the vocal cords to the desired depth. Meanwhile, the CPAP prong was fitted to the face. After placement of the catheter, the laryngoscope was removed. Surfactant was administered as a single bolus over 60 to 90 s and the tracheal catheter was immediately withdrawn. |
The infants were intubated and administered as in the intervention group, while they received PPV with a T piece resuscitator. After extubation, nCPAP was started as in the intervention group.
|
Effect of the LISA technique on the need for MV in the first 72 h of life. |
Need for MV:
There was a significant reduction in the need for MV in the LISA group (19% vs 40%, p < 0.01).
Second dose of surfactant and morbidities:
There was no difference between the two groups in the need for the second dose of surfactant, EOS, PDA, PIVH and mortality before hospital discharge.
In addition, duration of oxygen therapy, necrotizing enterocolitis and duration of NICU stay were significantly shorter in the LISA group. |
| Baskabadi et al. (2019)2020 Boskabaldi H., Maamouri G., Jomeh R.G., Zakerihamidi M. Comparative study of the effect of the administration of surfactant through a thin endotracheal catheter into trachea during spontaneous breathing with intubation (intubation-surfactant-extubation method). J Clin Neonatol. 2019;8:227-31.
|
40 (20/20) |
Direct laryngoscopy was performed to place a feeding tube into the infant's trachea. Then, during spontaneous breathing using nCPAP, surfactant was used for 1-3 min through the feeding tube, then the feeding tube was removed and NCPAP continued. |
The infants on NCPAP were intubated for surfactant administration and received the same amount of surfactant through the tracheal tube, then for 30-60 s they were submitted to bag-valve mask ventilation, then the tracheal tube was removed and NCPAP was restarted. |
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|
Duration of ventilation and duration of hospitalization:
The use of LISA reduced the need for MV in infants (p= 0.027), did not increase the side effects of RDS, and did not change the duration of the need for NCPAP and the duration of hospitalization (p > 0.05). |
| Olivier et al. (2017)2121 Olivier F., Nadeau S., Bélanger S., Julien A.S., Massé E., Ali N., et al. Efficacy of minimally invasive surfactant therapy in moderate and late preterm infants: a multicentre randomized control trial. Paediatr Child Health. 2017;22:120-4.
|
45 (24/21) |
Laryngoscopy was performed while patients received nCPAP support in which a sterile, flexible probe with forceps was inserted. |
Surfactant was administered only after intubation based on the judgment of the attending physician. |
Need for MV or the development of a pneumothorax requiring chest drainage. |
Mechanical ventilation or pneumothorax:
The incidence of the primary outcome was significantly lower in the intervention group (p < 0.001). |
| Kribs et al. (2015)2222 Kribs A., Roll C., Göpel W., Wieg C., Groneck P., Laux R., et al. Nonintubated Surfactant Application vs Conventional Therapy in Extremely Preterm Infants: a Randomized Clinical Trial. JAMA Pediatr. 2015;169:723-30.
|
211 (107/104) |
Laryngoscopy was performed while the child was breathing with the aid of nasal CPAP, then a catheter was introduced with forceps at an angle of approximately 120°; the catheter was fixed in this position and the laryngoscope removed. The infant's mouth was closed, and the surfactant was manually instilled for 30 to 120 s per minibolus. |
The infants were intubated, mechanical ventilation was started, and surfactant was administered through the endotracheal tube. Sedation and analgesia for intubation were not routinely used.
After administration, the infants were extubated and placed on non-invasive ventilation. |
Survival without bronchopulmonary dysplasia at 36 weeks GA, as determined by a standardized test. |
Bronchopulmonary dysplasia:
In the intervention group, 67.3% of all infants survived without BPD compared to 58.7% in the control group, i.e., no significant difference. The absolute risk reduction for the primary outcome was 8.6% (p = 0.20).
Mechanical ventilation:
Duration was shorter in the intervention group. No significant differences were observed in duration of respiratory support, use of supplemental oxygen, or incidence of pulmonary hemorrhage.
Pneumothorax:
The occurrence was significantly lower in the intervention vs control group (4.8% vs 12.6%; p= 0.04).
Intraventricular hemorrhage:
The intervention group had significantly less severe PIVH (10.3% vs 22.1%; p = 0.02).
Duration of hospitalization:
It was not significantly lower in the intervention group (103 vs 105 days; p = 0.11). |
| Han et al. (2020)2323 Han T., Liu H., Zhang H., Guo M., Zhang X., Duan Y., et al. Minimally invasive surfactant administration for the treatment of neonatal respiratory distress syndrome: a Multicenter Randomized Study in China. Front Pediatr. 2020;8:182.
|
298 (151/147) |
A laryngoscope was introduced through which the catheter tip was positioned with the aid of forceps up to 1.0 cm below the vocal cords. The laryngoscope and forceps were removed, and the child's mouth closed. The surfactant was instilled for 60 to 300 s per minibolus.
The catheter was removed immediately after administration. Sedation and analgesia were not used. During surfactant administration, nCPAP therapy was continued. |
They were intubated and received positive pressure ventilatory support. The surfactant was administered through an endotracheal tube. Positive pressure ventilatory support was performed following predefined patterns. Extubation criteria were established as FiO 2 < 0.3 and mean airway pressure (MAP) < 8 cm H2O. |
Difference in BPD morbidity between two groups of infants with LISA and INSURE at 36 weeks corrected gestational age. |
Bronchopulmonary dysplasia:
There were no clear benefits of LISA therapy on the incidence of BPD, but there was a trend towards a reduction in the incidence of BPD in the intervention group (29/151 vs. 138/147, 19.2 vs. 25.9%, p= 0.170).
BPD and PDA morbidity:
There was a significant reduction in morbidity in the BPD intervention group (9/31, 29.0 vs. 14/20, 70.0%, p= 0.004) and PDA (9/31, 29.0, vs. 13/21, 65.0%, p= 0.011).
Duration of ventilatory support:
There were no differences in the duration of nCPAP respiratory support and supplemental oxygen between the two groups.
Duration of hospitalization:
The infants in both groups remained in the NICU for almost 40 days.
Persistence of the ductus arteriosus:
Children in the INSURE group had higher rates compared to children in the LISA group (60.5 vs. 41.1%, p= 0.001). |
| Bao et al. (2015)2424 Bao Y., Zhang G., Wu M., Ma L., Zhu J. A pilot study of less invasive surfactant administration in very preterm infants in a Chinese tertiary center. BMC Pediatr. 2015;15:21.
|
90 (47/43) |
A 16-gage, 130 mm vascular catheter was marked to indicate the desired insertion depth (28-29 weeks: 1.5 cm, 30-32 weeks: 2 cm). While the neonates were on nCPAP, direct laryngoscopy was performed, and the catheter was inserted beyond the vocal cords to the required depth. Surfactant was administered in a standard dose with 5 bolus or more over 3-5 min. The tracheal catheter was immediately removed, and the infants were left on nCPAP. |
Surfactant instillation via endotracheal tube was performed with a few brief mechanical ventilations, a standard dose of surfactant was always divided into 2 or 3 bolus. The endotracheal tube was removed as soon as clinically possible after PS instillation, and the infant was switched to nCPAP. The entire procedure lasted about 3 min and took place without continuous distending pressure. |
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|
Mechanical ventilation:
The duration of MV and nCPAP was significantly shorter in the intervention group.
There were no significant differences in both rates of MV in the first 72 h and mean duration of oxygen need.
Mortality and morbidities:
There were no differences in mortality or in the incidence of bronchopulmonary dysplasia, intraventricular hemorrhage, retinopathy of prematurity and necrotizing enterocolitis. |
| Mosayebi et al. (2017)66 Mosayebi Z., Kadivar M., Taheri-Derakhsh N., Nariman S., Mahdi Marashi S., Farsi Z. A randomized trial comparing surfactant administration using InSurE technique and the minimally invasive surfactant therapy in preterm infants (28 to 34 weeks of gestation) with respiratory distress syndrome. J Compr Ped. 2017;8:e60724.
|
53 (24/26) |
The surfactant was instilled through a thin tracheal catheter, which was then removed. |
The infants were first intubated, administered surfactant by passing a feeding tube through the endotracheal tube, and then extubated after 30 s of positive pressure ventilation. |
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|
Ventilatory support:
The amount of oxygen needed by the LISA group was consistently lower than the other group in the first 48 h of life. The overall mean FiO2 was 42.5 ± 19.6 in the LISA group and 48.4 ± 21.6 in the INSURE group (p= 0.009).
Duration of hospitalization:
The mean length of stay in the neonatal intensive care unit was 7.3 ± 7.2 days in the MIST group and 9 ± 10.4 days in the INSURE group (p= 0.81).
Complications:
In terms of early and late complications, no difference was observed between the two groups. |
| Göpel et al. (2011)2525 Göpel W., Kribs A., Ziegler A., Laux R., Hoehn T., Wieg C., et al. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial. Lancet. 2011;378:1627-34.
|
220 (108/112) |
The infants received surfactant treatment during spontaneous breathing through a thin catheter inserted into the trachea by laryngoscopy if they required an inspired fraction of oxygen greater than 0.30. |
The infants in the standard care group were assigned to receive CPAP, rescue intubation, and surfactant treatment if needed. |
Any mechanical ventilation, or not being ventilated, but having a PCO2 greater than 65 mm Hg (8.6 kPa) or an FiO2 greater than 0.060 or both, for more than 2 h between 25 and 72 h of age. |
Need for mechanical ventilation:
The number of infants who received MV during the hospitalization was lower in the intervention group than in the control group (28% vs 46%; p= 0·008).
Duration of ventilatory support:
The total number of ventilation days was 599 in the control group vs 242 days in the
intervention group. |
| Bertini et al. (2017)2626 Bertini G., Coviello C., Gozzini E., Bianconi T., Bresci C., Leonardi V., et al. Change of cerebral oxygenation during surfactant treatment in preterm infants: "LISA" versus "InSurE" procedures. Neuropediatrics. 2017;48:98-103.
|
20 (10/10) |
A flexible nasogastric tube was placed in the trachea after direct visualization of the vocal cords with a laryngoscope and forceps. After placement of the catheter, the laryngoscope was removed, and surfactant was administered intratracheally within 30 to 60 s. After instillation, the catheter was immediately removed. The nCPAP support was maintained during the procedure. |
Performed with endotracheal tube and surfactant was instilled into the trachea within 30 s. After surfactant instillation, mechanical ventilation was performed for 1 min using a T piece device set at 18/5 cm H 2 O. Then, patients were immediately extubated and nCPAP resumed. |
Changes in measurement of cerebral regional oxygenation induced by LISA and INSURE procedures
and the possible differences between them. |
Regional cerebral oxygen saturation:
The LISA and INSURE procedures transiently decreased rSO2C in both groups, but the decrease was greater in the LISA group (p≤ 0.001).
|
| Mohammadizadeh et al. (2015)2727 Mohammadizadeh M., Ardestani A.G., Sadeghnia A.R. Early administration of surfactant via a thin intratracheal catheter in preterm infants with respiratory distress syndrome: feasibility and outcome. J Res Pharm Pract. 2015;4:31-6.
|
38 (19/19) |
Using the laryngoscope, a flexible catheter was inserted into the trachea and fixed with the aid of forceps at an angle of 120° This was fixed with two fingers and the laryngoscope removed. Then, surfactant was injected into the trachea for 1-3 min. At the end of the procedure, to ensure that the drug was not accidentally injected into the stomach, the orogastric tube was aspirated. During the procedure, nCPAP was applied continuously. After surfactant administration, FIO2 was gradually decreased as in the control group. |
The surfactant was administered through a 2.5F or 3F endotracheal tube inserted into the trachea. The child was temporarily separated from the CPAP. After bolus injection of drug into the trachea, positive pressure ventilation was applied using neopuff and continued for at least 1 min or until SpO2 reached 87% or greater. The endotracheal tube was then removed, and the child was switched back to nCPAP at the previous pressure.
FIO 2 was decreased at a rate of 5% every 1-2 min while SpO2 was maintained at the above-desired level. |
Need for mechanical ventilation up to 72 h after birth. |
Need for mechanical ventilation:
There was no significant difference between the groups regarding the need for
mechanical ventilation during the first 72 h of birth (3 [15.8%] in the control group vs. 2 [10.5%] in the
intervention group; p= 0.99).
Duration of ventilatory support:
The duration of oxygen therapy in the intervention group (fine catheter inserted into the trachea) was significantly shorter
than the control group (endotracheal tube) (243.7 ± 74.3 h vs. 476.8 ± 106.8 h; p= 0.018).
Adverse events:
The number of adverse events during surfactant administration was significantly lower in the intervention group than in the control group (6 [31.6%] vs.12 [63.2%]; p= 0.049).
Morbidities and mortality:
There was no significant difference between the two groups in terms of intraventricular hemorrhage rate, mortality and chronic lung disease.
|
| Yang et al. (2020)2828 Yang G., Hei M., Xue Z., Zhao Y., Zhang X., Wang C. Effects of less invasive surfactant administration (LISA) via a gastric tube on the treatment of respiratory distress syndrome in premature infants aged 32 to 36 weeks. Medicine. 2020;99:e19216.
|
97 (47/50) |
A gastric tube with an outer diameter of 2 mm was marked to indicate the desired insertion depth (32-34 weeks: 2 cm, 34-36 weeks: 2.5 cm). While the child was breathing via CPAP, a direct laryngoscope was introduced while the probe was grasped with Magill forceps to the desired position. The laryngoscope and clamp were removed. The infant's mouth was closed, and the surfactant was slowly injected over 1 to 3 min. After this step, 1 ml of air was introduced, and the gastric tube was removed. |
The infants in the INSURE group were treated with tracheal intubation and positive pressure artificial ventilation. Positive pressure ventilation continued for 3 min after surfactant injection and NCPAP was used after extubation. |
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|
There were no significant differences in reflux, asphyxia, Bradycardia (< 100 beats/min), apnea, FiO2, changes in PaO2 and PaCO2 1 hour after treatment between the groups.
During administration, blood pressure and SpO2 in the LISA group were more stable, and significant differences between the 2 groups were observed.
However, there were no significant differences in complications and outcomes between the 2 groups. |
| Li et al. (2016)2929 Li X.F., Cheng T.T., Guan R.L., Liang H., Lu W.N., Zhang J.H., et al. Effects of different surfactant administrations on cerebral autoregulation in preterm infants with respiratory distress syndrome. J Huazhong Univ Sci Technolog Med Sci. 2016;36:801-5.
|
44 (22/22) |
Surfactant via LISA was administered within 6 h of birth. The detailed protocol for LISA was derived from the literature. |
Surfactant via INSURE was administered within 6 h of birth. The detailed protocol for INSURE was derived from the literature. |
To compare the effect of the two methods of surfactant administration on brain autoregulation. |
Regional cerebral oxygen saturation: INSURE and LISA caused a transient impairment of brain autoregulation in infants with RDS, LISA was better than the INSURE technique in terms of duration of effect (< 5 min for LISA vs. 5-10 min for INSURE). |
| Kanmaz et al. (2013)1212 Kanmaz H.G., Erdeve O., Canpolat F.E., Mutlu B., Dilmen U. Surfactant administration via thin catheter during spontaneous breathing: randomized controlled trial. Pediatrics. 2013;131:e502-9.
|
200 (100/100) |
A laryngoscope was used to introduce a flexible and sterile nasogastric tube. The desired insertion depths beyond the vocal cords for preterm infants at 25 to 26, 27 to 28, and 29 to 32 weeks GA were 1.0, 1.5, and 2.0 cm, respectively. After placement of the catheter, the laryngoscope was removed. Surfactant was prepared and administered as a 1 bolus over 30 to 60 s and the tracheal catheter was immediately withdrawn. During the procedure, CPAP support was not interrupted. |
Patients were first intubated orally with a double-lumen endotracheal tube and surfactant was instilled into the trachea within 30 s. During surfactant instillation, manual lung inflation was performed using a T piece device with a pressure of 20/5 cm H2O, and then the patient was promptly extubated. Soon after extubation, nCPAP support was restarted, depending on the intervention group. No premedication, such as sedation or atropine, was used during either procedure. |
Need for mechanical ventilation in the first 72 h of life. |
Need for mechanical ventilation:
The need for mechanical ventilation in the first 72 h of life was significantly lower in the LISA group when compared to the INSURE group (30% vs 45%, p= 0.02).
Duration of ventilatory support:
The average duration of nCPAP and MV were significantly shorter in the LISA group (P values 0.006 and 0.002, respectively).
Bronchopulmonary dysplasia:
The rate was significantly lower among children treated with LISA and the incidence of moderate to severe BPD among patients who survived the disease was significantly higher in the INSURE Group (20.2% vs 10.3%, p= 0.009).
Mortality:
Overall mortality rates were similar in both groups (16% and 13%, p= 0.68).
|
| Halim et al. (2019)88 Halim A., Shirazi H., Riaz S., Gul S.S., Ali W. Less invasive surfactant administration in preterm infants with respiratory distress syndrome. J Coll Physicians Surg Pak. 2019;29:226-330.
|
100 (50/50) |
Surfactant was administered with the aid of a nasogastric tube. The upper respiratory tract was visualized with a laryngoscope and the catheter was passed 1-2 cm beyond the vocal cords. Surfactant was delivered within 1-3 min in small doses, while the child continued to breathe with nCPAP, during and after the procedure.
If catheterization was not possible within 20-30 s, the procedure was interrupted and tried again when the infant was stable. The tracheal catheter was removed immediately after the procedure. |
Infants were intubated and surfactant was successfully administered in 2-3 doses with an endotracheal tube at the same dose as the intervention group, while they received positive pressure ventilation via a T-piece resuscitator. After a brief period of positive pressure ventilation for 15-20 min, the endotracheal tube was removed, and the infants were placed on nCPAP. |
Need for mechanical ventilation. |
Need for mechanical ventilation:
The need for invasive mechanical ventilation was significantly higher in the INSURE group (60% (n= 30) vs. 30% (n= 15), p < 0.05} compared to the LISA group.
Duration of mechanical ventilation:
The duration of mechanical ventilation was also significantly longer in the INSURE group with a median of 71 (IQR 62) vs. 40 (IQR 75) hours, p < 0.05 when compared to the LISA group.
Morbidities:
No significant differences were observed in either group based on complication rate (pneumothorax, PDA, pulmonary hemorrhage). In the INSURE group 5 (10%) developed pneumothorax compared with 2 (4%) in the LISA group (p= 0.625).
Mortality:
There were better survival rates in the LISA group (62% discharged, 38% died) compared with the INSURE group (44% discharged, 56% died), with no significant value. |
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