Determination of Lung Maturity and Prediction of RDS at Birth

Henrik Axel Verder

Status: Completed

Conditions: RDS; Premature Birth

Study type: Observational

Funder types: Other

Identifiers

NCT02076126

Holb.SJ-384

Details and patient eligibility

About

The overall objective is to identify quickly after birth the preterm infants who will develop respiratory distress syndrome (RDS) for the purpose of treating them as early as possible with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen treatment.

We have therefore developed a quick test, which we believe will be ideal for this type of diagnostics, and will now test the method in a preclinical trial.

Full description

In at least 135 preterm infants with gestational age 24-32 weeks we will collect gastric aspirate and hypopharyngeal secretion. The infants are stratified into three groups: gestational age 24-25 weeks, 26-29 weeks and 30-31 weeks.

The aspirates will be frozen at -20 centigrade and lecithin-sphingomyelin ratio (L/S) will be analysed retrospectively using Fourier Transform Infrared Spectroscopy.

The infants will be monitored for the first five days with regard to possible development of RDS.

Clinical and biochemical data will be compared retrospectively.

There a no intervention procedures.

Enrollment: 145 patients

Sex: All

Ages: 1 to 30 minutes old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants with gestational ages of 24 (24+0) to 32 (31+6) weeks.
• Age < ½ hour

Exclusion criteria

• Lack of informed consent
• lack of aspirate

Trial design

145 participants in 2 patient groups

Gastric aspirate

Description:

L/S ratio on the gastric aspirates are retrospectively compared with the possible development of RDS

Hypopharyngeal secretion

Description:

L/S ratio on the hypopharyngeal secretions are retrospectively compared with the possible development of RDS