Bronchopulmonary Dysplasia, Gastroesophageal Reflux
Conditions
Brief summary
Bronchopulmonary dysplasia (BPD) is a common condition in the low birth weight infants. Although most of the BPD symptoms improved after a regular treatment in infancy, there are still a few late complications left such as the frequent respiratory symptoms, a slower weight gain and even sudden death. These late complications have made so much trouble to the healthcare of BPD infants. How to find the risk factors and to reduce the prevalence of these late symptoms becomes necessary. In this study, a cohort of BPD infants was observed with the late complications obtained by a monthly followed up for 18 months after discharge, the prevalence and risk factors of the late complications of BPD were analyzed by logistic regression. As one of the risk factors, GER was verified whether to play a critical role in these late complications.
Interventions
None listed
Sponsors
Shengjing Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* the extremely premature infants with bronchopulmonary dysplasia
Exclusion criteria
* other congenital malformations such as gastrointestinal and or neurogenic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Late Complications of BPD Infants | 18 months | 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. |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Extremely Premature Infants With Bronchopulmonary Dysplasia 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. | 116 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discontinued GER | 3 |
| Overall Study | Excluded | 19 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Refused to take part in | 37 |
Baseline characteristics
| Characteristic | Extremely Premature Infants With Bronchopulmonary Dysplasia | — |
|---|---|---|
| 1min Apgar 1 min Apgar>=7 | 89 Participants | — |
| 1min Apgar 1min Apgar<7 | 27 Participants | — |
| Age, Customized gestational age<30 week | 51 participants | — |
| Age, Customized gestational age>=30 week | 65 participants | — |
| Application of caffeine no | 37 Participants | — |
| Application of caffeine yes | 79 Participants | — |
| Application of pulmonary surfactant no | 40 Participants | — |
| Application of pulmonary surfactant yes | 76 Participants | — |
| birth weight <1500g | 71 Participants | — |
| birth weight >1500g | 45 Participants | — |
| Gastroesophageal reflux Acid GER | 21 Participants | — |
| Gastroesophageal reflux DGER | 28 Participants | — |
| Gastroesophageal reflux No | 67 Participants | — |
| Invasive ventilation Invasive ventilation<7 days | 88 Participants | — |
| Invasive ventilation Invasive ventilation>=7 days | 28 Participants | — |
| patent ductus arteriosus no | 87 Participants | — |
| patent ductus arteriosus yes | 29 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 44 Participants | — |
| Sex: Female, Male Male | 72 Participants | — |
| Ventilator-associated Pneumonia no | 61 Participants | — |
| Ventilator-associated Pneumonia yes | 55 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 116 |
| other Total, other adverse events | 69 / 116 |
| serious Total, serious adverse events | 64 / 116 |
Outcome results
Primary
the Late Complications of BPD Infants
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.
Time frame: 18 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Extremely Premature Infants With Bronchopulmonary Dysplasia | the Late Complications of BPD Infants | respiratory symptoms | 57 Participants |
| Extremely Premature Infants With Bronchopulmonary Dysplasia | the Late Complications of BPD Infants | Vomiting when feeding | 45 Participants |
| Extremely Premature Infants With Bronchopulmonary Dysplasia | the Late Complications of BPD Infants | retinopathy of prematurity | 30 Participants |
| Extremely Premature Infants With Bronchopulmonary Dysplasia | the Late Complications of BPD Infants | hypoxic ischemic injury | 4 Participants |
| Extremely Premature Infants With Bronchopulmonary Dysplasia | the Late Complications of BPD Infants | sudden infant death syndrome | 1 Participants |
| Extremely Premature Infants With Bronchopulmonary Dysplasia | the Late Complications of BPD Infants | rehospitalization | 31 Participants |