NCT05788562

Brief Summary

A monocentric prospective study was conducted to find the relevance between the level of fetal hemoglobin and short-term complications in extremely preterm infants

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

March 29, 2023

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

March 15, 2023

Last Update Submit

March 15, 2023

Conditions

Fetal Hemoglobin

Outcome Measures

Primary Outcomes (1)

  • Occurrence and severity of early complications in premature infants

    include necrotizing enterocolitis,bronchopulmonary dysplasia,retinopathy, Intraventricular hemorrhage above degree Ⅱ,leukomalacia,late-onset sepsis

    2022.1-2023.1

Study Arms (2)

Experimental group

Incorporate blood gas analysis indicators in D1-D7, after birth,1 week before and on the day of onset of early complications

Control group

Incorporate blood gas analysis indicators in D1-D7,D14,D28after birth and the day of diacharge

Eligibility Criteria

Age1 Day - 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm infants with gestational age \<32 weeks or birth weight \<1500g

You may qualify if:

  • Preterm infants with gestational age \<32 weeks or birth weight \<1500g
  • Parents agree to attend

You may not qualify if:

  • serious functional or organic diseases
  • severe congenital deformity
  • parents reject to attend

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Qu Yangming

CONTACT

15844092520quym@jlu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 29, 2023

Study Start

April 1, 2023

Primary Completion

February 18, 2024

Study Completion

May 30, 2024

Last Updated

March 29, 2023

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)