NCT03675425

Brief Summary

The study was designed to assess whether chest shielding during phototherapy reduces the incidence of PDA, as assessed by serial echocardiographic examinations, in a population of extremely preterm infants born at lower 30 week gestation.

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
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

July 8, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

December 11, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

July 15, 2018

Last Update Submit

December 9, 2018

Conditions

Patent Ductus Arteriosus After Premature BirthHyper Bilirubinemia

Keywords

Chest shieldingPatent Ductus ArteriosusChest Childing

Outcome Measures

Primary Outcomes (1)

  • echocardiographic examination

    presence of Patent Ductus arteriozus

    first week

Study Arms (2)

Group 1: non chest shielding

EXPERIMENTAL

non chest shielding generic name: non dosage: non frequency and duration: in first 48 h eco with pad diameter will be measured in before and after phototherapy,

Other: Group 1: non chest shielding

Group 2: chest shielding

PLACEBO COMPARATOR

chest shielding generic name: Phototrephy dosage: non frequency and duration: in first 48 h echo with pad diameter will be measured in before and after phototherapy,

Other: Group 2: chest shielding

Interventions

Group 1: non chest shieldingOTHER

non chest childin: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,

Group 1: non chest shielding
Group 2: chest shieldingOTHER

chest childing: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,

Group 2: chest shielding

Eligibility Criteria

Age3 Days - 1 Week
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational week ≤ 30 weeks receiving phototherapy due to jaundice and infants who can perform echocardiography before and after treatment will be included in the study.

You may not qualify if:

  • Babies with congenital heart disease.
  • Infants with major structural anomalies and infants who can not undergo echocardiography before or after treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Matarnity Teaching

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Evrim Alyamaç Dizdar, MD

    zekai tahir burak matarnity teaching hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2018

First Posted

September 18, 2018

Study Start

July 8, 2018

Primary Completion

January 30, 2019

Study Completion

February 28, 2019

Last Updated

December 11, 2018

Record last verified: 2018-07

Locations

TU(1)