Respiratory Trends During Blood Transfusions in Newborns.

NCT ID: NCT06443515

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-01-15

Brief Summary

The prevalence of transfusion reactions is between 1 and 11% of transfusions. Most reactions are mild and do not pose a life-threatening risk to the patient. More serious problems may be the only manifestations that lead to suspicion of a transfusion reaction.

Most noninfectious transfusion reactions are immune-mediated. Two main types of reactions can be distinguished: TACO (transfusion associated cardiac overload, which is a cardiogenic pulmonary edema) and TRALI (transfusion related acute lung injury, non-cardiogenic pulmonary edema).

Although TRALI are diagnoses of exclusion, the presence of noncardiogenic pulmonary edema and respiratory problems in the vicinity of blood product transfusions should raise suspicion. Other signs of TRALI are hypotension and tachycardia, while in TACO arterial hypertension with positive water balance can be observed.

According to previous reports, the prevalence of transfusion reactions in the neonatal population is approximately 8%. Factors associated with these reactions are low birth weight and low gestational age. However, diagnostic criteria of respiratory transfusion reactions are not uniform across studies, and often the generic terms "acute lung injury" have been used.

Therefore, the primary objective of this study is to evaluate the respiratory trend during blood transfusions; secondary objectives are the study of risk factors for the development of respiratory worsening and the possible association with complications.

Conditions

Blood Transfusion Complication; Blood Transfusion Associated Adverse Reactions; Respiratory Complication; Respiratory Morbidity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

study group

All infants undergoing blood transfusions will be enrolled in the study

Group Type: OTHER

lung ultrasound

Intervention Type: DIAGNOSTIC_TEST

Lung ultrasound examinations will be performed within 6 hours before and after blood transfusion to assess interstitial-alveolar fluid retention and calculate a LUS score

Interventions

lung ultrasound

Lung ultrasound examinations will be performed within 6 hours before and after blood transfusion to assess interstitial-alveolar fluid retention and calculate a LUS score

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• admitted newborns requiring blood transfusions as per local practice and/or international guidelines

Exclusion Criteria

• newborns with major malformations
• need for palliative care
• lack of informed consent

• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefano Nobile, MD, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Gemelli IRCCS

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefano Nobile, MD, PhD, MSc

Role: CONTACT

stefano.nobile@policlinicogemelli.it

+39 06 30151

Stefano Nobile

Role: CONTACT

stefano.nobile@policlinicogemelli.it

Facility Contacts

Stefano Nobile, MD, PhD, MSc

Role: primary

stefano.nobile@policlinicogemelli.it

+390630151

Other Identifiers

6438

Identifier Type: -

Identifier Source: org_study_id