NCT06082414

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2020

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

October 4, 2023

Last Update Submit

October 9, 2023

Conditions

Bronchopulmonary DysplasiaDeath

Outcome Measures

Primary Outcomes (4)

  • incidences

    to investigate incidences of bronchopulmonary dysplasia

    at 36 weeks' corrected age (CA) or at discharge

  • risk factors

    to investigate risk factors of bronchopulmonary dysplasia

    at 36 weeks' corrected age (CA) or at discharge

  • incidences of delivery room resuscitation

    to investigate incidences of delivery room resuscitation

    on admission

  • risk factors of delivery room resuscitation

    to investigate risk factors of delivery room resuscitation

    on admission

Study Arms (3)

<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

<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

≥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

Interventions

no interventionsOTHER

no interventions because of an observational study

<28 weeks and <1000 grams<28 weeks and ≥1000 grams≥28 weeks and <1000 grams

Eligibility Criteria

AgeUp to 72 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

infants with a birth weight \<1000grams or a gestational age \<28 weeks;

You may qualify if:

  • born between January 1, 2015, and December 31, 2018;
  • a birth weight \<1000grams or a gestational age \<28 weeks;
  • admitted within 72 hours after birth.

You may not qualify if:

  • No medical history in the electronic record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qi Feng

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (1)

  • Li S, Feng Q, Huang X, Tian X, Zhou Y, Ji Y, Zhai S, Guo W, Zheng R, Wang H. Association of different doses of antenatal corticosteroids exposure with early major outcomes and early weight loss percentage in extremely preterm infants or extremely low birthweight infants: a multicentre cohort study. BMJ Paediatr Open. 2024 Jun 18;8(1):e002506. doi: 10.1136/bmjpo-2024-002506.

    PMID: 38897621DERIVED

MeSH Terms

Conditions

Bronchopulmonary DysplasiaDeath

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qi Feng

    Peking University First Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post doctor, Attending physician

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 13, 2023

Study Start

January 30, 2019

Primary Completion

January 29, 2020

Study Completion

January 29, 2020

Last Updated

October 13, 2023

Record last verified: 2023-10

Locations

CN(1)