Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants

• Sponsor: Peking University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06082414
• Collaborator: Peking University First Hospital (Other), Peking University People's Hospital (Other), Peking University Third Hospital (Other), Tianjin Central Hospital of Gynecology Obstetrics (Other), Peking Union Medical College Hospital (Other), Beijing Children's Hospital (Other), Beijing Friendship Hospital (Other), Shanxi Provincial Maternity and Children's Hospital (Other), The Second Hospital of Hebei Medical University (Other), Handan Central Hospital (Other), Xingtai People's Hospital (Other), Tianjin Medical University General Hospital (Other), The Affiliated Hospital of Inner Mongolia Medical University (Other), Children's Hospital of Hebei Province (Other), Tianjin First Central Hospital (Other), Chifeng Municipal Hospital (Other), Tianjin Medical University Second Hospital (Other), PLA Rocket Force Characteristic Medical Center (Other)
• Enrollment: 1,200
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 100.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Bronchopulmonary Dysplasia; Death	Other: no interventions

Detailed 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

Study Design

• Study Type: Observational
• Actual Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
• Actual Study Start Date: Jan 30, 2019
• Actual Primary Completion Date: Jan 29, 2020
• Actual Study Completion Date: Jan 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
<28 weeks and <1000 grams By gestational age and birth weight, infants were classified into 3 groups. No interventions because of an observational study.	Other: no interventions; no interventions because of an observational study
<28 weeks and ≥1000 grams By gestational age and birth weight, infants were classified into 3 groups. No interventions because of an observational study.	Other: no interventions; no interventions because of an observational study
≥28 weeks and <1000 grams By gestational age and birth weight, infants were classified into 3 groups. No interventions because of an observational study.	Other: no interventions; no interventions because of an observational study

Outcome Measures

Primary Outcome Measures

1. incidences [at 36 weeks' corrected age (CA) or at discharge]

   to investigate incidences of bronchopulmonary dysplasia

2. risk factors [at 36 weeks' corrected age (CA) or at discharge]

   to investigate risk factors of bronchopulmonary dysplasia

3. incidences of delivery room resuscitation [on admission]

   to investigate incidences of delivery room resuscitation

4. risk factors of delivery room resuscitation [on admission]

   to investigate risk factors of delivery room resuscitation

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 72 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qi Feng	Beijing	Beijing	China	100034

Sponsors and Collaborators

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

Investigators

• Study Chair: Qi Feng, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Li Shuaijun, Post doctor, Attending physician, Peking University
• ClinicalTrials.gov Identifier: NCT06082414
• Other Study ID Numbers: 2019(21)
• First Posted: Oct 13, 2023
• Last Update Posted: Oct 13, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bronchopulmonary Dysplasia; Birth Weight

Study Results

No Results Posted as of Oct 13, 2023