Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03217162
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 59.9
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

Condition or Disease	Intervention/Treatment	Phase
ARDS; RDS; Surfactant	Drug: surfactant combined with mechanical ventilation (MV); Drug: mechanical ventilation (MV)	N/A

Detailed Description

To date, surfactant is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that surfactant does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of bronchopulmonary dysplasia(BPD) in term and late preterm infants with meconium aspiration syndrome. Therefore, a reasonable speculation is that preterm infants with ARDS do not benefit from one dose of surfactant. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from surfactant. In the era of pre-ARDS, the preterm infants fulfilling the definition of ARDS may have been considered as respiratory distress syndrome (ARDS) in the first three days after birth.

According to the diagnostic criteria of neonatal ARDS, a key procedure for diagnosis of neonatal ARDS is to exclude the newborn infants with RDS. But no detailed procedures are available to differentiate RDS from ARDS according the guideline of european RDS and definition of neonatal ARDS.

Therefore, there are two aim in the present study. 1. to proposel a new definition of RDS; 2. to assess the beneficial effects of surfactant on neonatal ARDS.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
• Actual Study Start Date: Aug 1, 2017
• Anticipated Primary Completion Date: Jul 30, 2022
• Anticipated Study Completion Date: Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: surfactant combined with mechanical ventilation surfactant is given to the infant with ARDS.	Drug: surfactant combined with mechanical ventilation (MV); surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS
Active Comparator: mechanical ventilation mechanical ventilation is given to the infant with ARDS.	Drug: mechanical ventilation (MV); mechanical ventilation (MV) is given to the infant with ARDS

Outcome Measures

Primary Outcome Measures

1. death [at 36 weeks' gestational age or before discharge from hospital]

   neonates died

2. bronchopulmonary dysplasia(BPD) [at 36 weeks' gestational age or before discharge from hospital]

   neonates were diagnosed with BPD

3. BPD and/or death [at 36 weeks' gestational age or before discharge from hospital]

   neonates were diagnosed with BPD and/or death

Secondary Outcome Measures

1. Bayley Scales of Infant Development [at 2 months old and 2 years old]

   the survival are assessed by Bayley Scales of Infant Development

2. haemodynamically significant patent ductusarteriosus (hsPDA) [at 36 weeks' gestational age or before discharge from hospital]

   neonates were diagnosed with hsPDA

3. retinopathy of prematurity (ROP)> 2nd stages [at 36 weeks' gestational age or before discharge from hospital]

   neonates were diagnosed with ROP> 2nd stages

4. necrotizing enterocolitis (NEC) ≥ 2nd stages [at 36 weeks' gestational age or before discharge from hospital]

   neonates were diagnosed with NEC ≥ 2nd stages

5. intraventricular hemorrhage(IVH)>2nd grades [at 36 weeks' gestational age or before discharge from hospital]

   neonates were diagnosed with IVH >2nd grades

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Minutes to 28 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. infant less than 28 days

2. diagnosis of ARDS or RDS or both

3. informed parental consent has been obtained

Exclusion Criteria:

1. major congenital malformations or complex congenital heart disease or chromosomal abnormalities

2. transferred out of the neonatal intensive care unit without treatment

3. upper respiratory tract abnormalities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of neonatology, Children's hospital of Chongqing Medical University	Chongqing	Chongqing	China	400014

Sponsors and Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Investigators

• Study Director: Shi Yuan, PhD,MD, Children's Hospital of Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ma Juan, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• ClinicalTrials.gov Identifier: NCT03217162
• Other Study ID Numbers: surfactant for ARDS
• First Posted: Jul 13, 2017
• Last Update Posted: Feb 17, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pulmonary Surfactants

Study Results

No Results Posted as of Feb 17, 2021