Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06082414
• Other study ID #: 2019(21)
• Status: Completed
• Start date: January 30, 2019
• Est. completion date: January 29, 2020

Study information

• Verified date: October 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China

Description:

to estimate incidences and risk factors of bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: January 29, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

Inclusion Criteria:

1. born between January 1, 2015, and December 31, 2018;

2. a birth weight <1000grams or a gestational age <28 weeks;

3. admitted within 72 hours after birth. Exclusion Criteria: No medical history in the electronic record

Related Conditions & MeSH terms

• Birth Weight
• Bronchopulmonary Dysplasia
• Death

Intervention

Other:
• no interventions
no interventions because of an observational study

Locations

Country	Name	City	State
China	Qi Feng	Beijing	Beijing

Sponsors (19)

Lead Sponsor

Collaborator

Peking University

Beijing Children's Hospital, Beijing Friendship Hospital, Chifeng Municipal Hospital, Children's Hospital of Hebei Province, Handan Central Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital, PLA Rocket Force Characteristic Medical Center, Shanxi Provincial Maternity and Children's Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The Second Hospital of Hebei Medical University, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin First Central Hospital, Tianjin Medical University General Hospital, Tianjin Medical University Second Hospital, Xingtai People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidences	to investigate incidences of bronchopulmonary dysplasia	at 36 weeks' corrected age (CA) or at discharge
Primary	risk factors	to investigate risk factors of bronchopulmonary dysplasia	at 36 weeks' corrected age (CA) or at discharge
Primary	incidences of delivery room resuscitation	to investigate incidences of delivery room resuscitation	on admission
Primary	risk factors of delivery room resuscitation	to investigate risk factors of delivery room resuscitation	on admission