Trial Outcomes & Findings for GER Poses a Potential Risk for Late Complications of BPD (NCT NCT03014453)
NCT ID: NCT03014453
Last Updated: 2020-03-26
Results Overview
In all patients, complications were evaluated via questionnaires at 3, 6, 9 and 12 months corrected for premature age, including respiratory symptoms (including home respiratory support, respiratory medication administration, cough without cold at least once per week, re-hospitalization due to respiratory diseases), vomiting when feeding, hypoxic ischemic injury, retinopathy of prematurity, rehospitalization and sudden death.
COMPLETED
187 participants
18 months
2020-03-26
Participant Flow
The cohort study was conducted with BPD infants born≤32 weeks gestational age (GA) between January 2017 and July 2018 at Shengjing Hospital of China Medical University.The BPD was diagnosed at 36 weeks postmenstrual age (PMA) on the National Heart, Lung and Blood Institute classification and categorized as "mild, moderate or severe".
Participant milestones
| Measure |
Extremely Premature Infants With Bronchopulmonary Dysplasia
Single arm-extremely premature infants with bronchopulmonary dysplasia
|
|---|---|
|
Overall Study
STARTED
|
187
|
|
Overall Study
COMPLETED
|
116
|
|
Overall Study
NOT COMPLETED
|
71
|
Reasons for withdrawal
| Measure |
Extremely Premature Infants With Bronchopulmonary Dysplasia
Single arm-extremely premature infants with bronchopulmonary dysplasia
|
|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Discontinued GER
|
3
|
|
Overall Study
Excluded
|
19
|
|
Overall Study
Refused to take part in
|
37
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Extremely Premature Infants With Bronchopulmonary Dysplasia
n=116 Participants
This observational cohort study was conducted with BPD infants born≤32 weeks gestational age (GA) at Shengjing Hospital of China Medical University neonatal intensive care unit (NICU). None of them received antacid medications, inhaled medications, or diuretics.
|
|---|---|
|
Age, Customized
gestational age>=30 week
|
65 participants
n=116 Participants
|
|
Age, Customized
gestational age<30 week
|
51 participants
n=116 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=116 Participants
|
|
birth weight
>1500g
|
45 Participants
n=116 Participants
|
|
birth weight
<1500g
|
71 Participants
n=116 Participants
|
|
1min Apgar
1min Apgar<7
|
27 Participants
n=116 Participants
|
|
1min Apgar
1 min Apgar>=7
|
89 Participants
n=116 Participants
|
|
Invasive ventilation
Invasive ventilation>=7 days
|
28 Participants
n=116 Participants
|
|
Invasive ventilation
Invasive ventilation<7 days
|
88 Participants
n=116 Participants
|
|
Application of pulmonary surfactant
yes
|
76 Participants
n=116 Participants
|
|
Application of pulmonary surfactant
no
|
40 Participants
n=116 Participants
|
|
Application of caffeine
yes
|
79 Participants
n=116 Participants
|
|
Application of caffeine
no
|
37 Participants
n=116 Participants
|
|
Ventilator-associated Pneumonia
yes
|
55 Participants
n=116 Participants
|
|
Ventilator-associated Pneumonia
no
|
61 Participants
n=116 Participants
|
|
patent ductus arteriosus
yes
|
29 Participants
n=116 Participants
|
|
patent ductus arteriosus
no
|
87 Participants
n=116 Participants
|
|
Gastroesophageal reflux
No
|
67 Participants
n=116 Participants
|
|
Gastroesophageal reflux
Acid GER
|
21 Participants
n=116 Participants
|
|
Gastroesophageal reflux
DGER
|
28 Participants
n=116 Participants
|
PRIMARY outcome
Timeframe: 18 monthsIn all patients, complications were evaluated via questionnaires at 3, 6, 9 and 12 months corrected for premature age, including respiratory symptoms (including home respiratory support, respiratory medication administration, cough without cold at least once per week, re-hospitalization due to respiratory diseases), vomiting when feeding, hypoxic ischemic injury, retinopathy of prematurity, rehospitalization and sudden death.
Outcome measures
| Measure |
Extremely Premature Infants With Bronchopulmonary Dysplasia
n=116 Participants
This observational cohort study was conducted with BPD infants born≤32 weeks gestational age (GA) at Shengjing Hospital of China Medical University neonatal intensive care unit (NICU). None of them received antacid medications, inhaled medications, or diuretics.
|
|---|---|
|
the Late Complications of BPD Infants
respiratory symptoms
|
57 Participants
|
|
the Late Complications of BPD Infants
Vomiting when feeding
|
45 Participants
|
|
the Late Complications of BPD Infants
retinopathy of prematurity
|
30 Participants
|
|
the Late Complications of BPD Infants
hypoxic ischemic injury
|
4 Participants
|
|
the Late Complications of BPD Infants
sudden infant death syndrome
|
1 Participants
|
|
the Late Complications of BPD Infants
rehospitalization
|
31 Participants
|
Adverse Events
Extremely Premature Infants With Bronchopulmonary Dysplasia
Serious adverse events
| Measure |
Extremely Premature Infants With Bronchopulmonary Dysplasia
n=116 participants at risk
This observational cohort study was conducted with BPD infants born≤32 weeks gestational age (GA) at Shengjing Hospital of China Medical University neonatal intensive care unit (NICU). None of them received antacid medications, inhaled medications, or diuretics.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
8.6%
10/116 • Number of events 116 • 18 month
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
8.6%
10/116 • Number of events 116 • 18 month
|
|
Respiratory, thoracic and mediastinal disorders
cyanosis
|
8.6%
10/116 • Number of events 116 • 18 month
|
|
Respiratory, thoracic and mediastinal disorders
intermittent apnea
|
4.3%
5/116 • Number of events 116 • 18 month
|
|
Eye disorders
retinopathy of prematurity
|
25.9%
30/116 • Number of events 116 • 18 month
|
|
Nervous system disorders
hypoxic ischemic injury
|
3.4%
4/116 • Number of events 116 • 18 month
|
|
Respiratory, thoracic and mediastinal disorders
Re-hospitalization
|
26.7%
31/116 • Number of events 116 • 18 month
|
Other adverse events
| Measure |
Extremely Premature Infants With Bronchopulmonary Dysplasia
n=116 participants at risk
This observational cohort study was conducted with BPD infants born≤32 weeks gestational age (GA) at Shengjing Hospital of China Medical University neonatal intensive care unit (NICU). None of them received antacid medications, inhaled medications, or diuretics.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
cough without cold
|
37.9%
44/116 • Number of events 116 • 18 month
|
|
General disorders
Vomiting when feeding
|
38.8%
45/116 • Number of events 116 • 18 month
|
Additional Information
Dr. Shucheng Zhang
Shengjing Hospital of China Medical University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place