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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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Extremely Premature Infants with Bronchopulmonary Dysplasia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital | Shenyang | Liaoning | 110004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29229093 | Background | Kalikkot Thekkeveedu R, Guaman MC, Shivanna B. Bronchopulmonary dysplasia: A review of pathogenesis and pathophysiology. Respir Med. 2017 Nov;132:170-177. doi: 10.1016/j.rmed.2017.10.014. Epub 2017 Oct 24. | |
| 30119711 | Background | Bonadies L, Zaramella P, Porzionato A, Muraca M, Baraldi E. Bronchopulmonary dysplasia: what's new on the horizon? Lancet Child Adolesc Health. 2018 Aug;2(8):549-551. doi: 10.1016/S2352-4642(18)30181-0. Epub 2018 Jun 27. No abstract available. |
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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".
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| ID | Title | Description |
|---|---|---|
| FG000 | Extremely Premature Infants With Bronchopulmonary Dysplasia | Single arm-extremely premature infants with bronchopulmonary dysplasia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Gestational age at birth is reported |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | No | 18 months |
|
18 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cough without cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | cough without cold at least once per week |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shucheng Zhang | Shengjing Hospital of China Medical University | 862496615 | 57911 | zhangshucheng76@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2020 | Mar 25, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2020 | Mar 25, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| 30201135 | Background | Papagianis PC, Pillow JJ, Moss TJ. Bronchopulmonary dysplasia: Pathophysiology and potential anti-inflammatory therapies. Paediatr Respir Rev. 2019 Apr;30:34-41. doi: 10.1016/j.prrv.2018.07.007. Epub 2018 Jul 29. |
| 28668285 | Background | Perez Tarazona S, Solano Galan P, Bartoll Alguacil E, Alfonso Diego J. Bronchopulmonary dysplasia as a risk factor for asthma in school children and adolescents: A systematic review. Allergol Immunopathol (Madr). 2018 Jan-Feb;46(1):87-98. doi: 10.1016/j.aller.2017.02.004. Epub 2017 Jun 28. |
| 29958703 | Background | Clyman RI. Patent ductus arteriosus, its treatments, and the risks of pulmonary morbidity. Semin Perinatol. 2018 Jun;42(4):235-242. doi: 10.1053/j.semperi.2018.05.006. Epub 2018 May 10. |
| 28188008 | Background | Nagiub M, Kanaan U, Simon D, Guglani L. Risk Factors for Development of Pulmonary Hypertension in Infants with Bronchopulmonary Dysplasia: Systematic Review and Meta-Analysis. Paediatr Respir Rev. 2017 Jun;23:27-32. doi: 10.1016/j.prrv.2016.11.003. Epub 2016 Nov 22. |
| 1896295 | Background | Vandenplas Y, Goyvaerts H, Helven R, Sacre L. Gastroesophageal reflux, as measured by 24-hour pH monitoring, in 509 healthy infants screened for risk of sudden infant death syndrome. Pediatrics. 1991 Oct;88(4):834-40. |
| 15758900 | Background | Hassall E. Decisions in diagnosing and managing chronic gastroesophageal reflux disease in children. J Pediatr. 2005 Mar;146(3 Suppl):S3-12. doi: 10.1016/j.jpeds.2004.11.034. |
| 29470322 | Background | Rosen R, Vandenplas Y, Singendonk M, Cabana M, DiLorenzo C, Gottrand F, Gupta S, Langendam M, Staiano A, Thapar N, Tipnis N, Tabbers M. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2018 Mar;66(3):516-554. doi: 10.1097/MPG.0000000000001889. |
| 25752807 | Background | Cohen S, Bueno de Mesquita M, Mimouni FB. Adverse effects reported in the use of gastroesophageal reflux disease treatments in children: a 10 years literature review. Br J Clin Pharmacol. 2015 Aug;80(2):200-8. doi: 10.1111/bcp.12619. Epub 2015 Jun 11. |
| 30429693 | Background | Shakir AK, Altaf MA. Azithromycin Induces Migrating Motor Complexes in Pediatric Patients Undergoing Antroduodenal Motility Studies. J Pediatr Pharmacol Ther. 2018 Sep-Oct;23(5):390-394. doi: 10.5863/1551-6776-23.5.390. |
| 20732945 | Background | Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23. |
| 25765705 | Background | Parad RB, Davis JM, Lo J, Thomas M, Marlow N, Calvert S, Peacock JL, Greenough A. Prediction of respiratory outcome in extremely low gestational age infants. Neonatology. 2015;107(4):241-8. doi: 10.1159/000369878. Epub 2015 Mar 3. |
| 32450238 | Derived | Wang LJ, Hu Y, Wang W, Zhang CY, Bai YZ, Zhang SC. Gastroesophageal Reflux Poses a Potential Risk for Late Complications of Bronchopulmonary Dysplasia: A Prospective Cohort Study. Chest. 2020 Oct;158(4):1596-1605. doi: 10.1016/j.chest.2020.05.523. Epub 2020 May 22. |
| Refused to take part in |
|
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| birth weight | Count of Participants | Participants |
|
| 1min Apgar | 1 min Apgar score was described. If the 1min Apgar score <7, it was considered neonatal asphyxia，otherwise it was regarded as normal infant. | Count of Participants | Participants |
|
| Invasive ventilation | Describes the duration of the use of invasive ventilation during hospitalization | Count of Participants | Participants |
|
| Application of pulmonary surfactant | Describes whether pulmonary surfactant has been used | Count of Participants | Participants |
|
| Application of caffeine | Describes whether caffeine therapy has been used | Count of Participants | Participants |
|
| Ventilator-associated Pneumonia | Cases of ventilator-associated pneumonia during hospitalization | Count of Participants | Participants |
|
| patent ductus arteriosus | Cases of patent ductus arteriosus | Count of Participants | Participants |
|
| Gastroesophageal reflux | The cases were diagnosed as gastroesophageal reflux by pH-MII and determination of gastric sodium ions． | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 116 |
| 64 |
| 116 |
| 69 |
| 116 |
| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| cyanosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| intermittent apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| retinopathy of prematurity | Eye disorders | Systematic Assessment |
|
| hypoxic ischemic injury | Nervous system disorders | Systematic Assessment |
|
| Re-hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
|
| Vomiting when feeding | General disorders | Systematic Assessment |
|
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| D004066 | Digestive System Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |