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Prediction of lung maturity and RDS at birth

Determination by mid-infrared spectroscopy of lecithin-sphingomyelin ratio (L/S) on gastric aspirates in infants <1500 g

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025128
Enrollment
Unknown
Registered
2019-08-13
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NRDS

Interventions

Gold Standard:History,Xray and lung maturity test.
Index test:Measure&#32
the&#32
lecithin-sphingomyelin&#32
ratio&#32
(L/S)&#32
in&#32
gastric&#32
aspirate.

Sponsors

Northwest Women's and Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.120 inborn premature infants with birth weight <1500 g. 2.Informed consent. Parents informed either before birth or soon after; 3.GAS obtained within 45 mins after birth; 4.Nasal CPAP or infant breathing spontaneously.

Exclusion criteria

Exclusion criteria: 1. Mechanical ventilation (MV) before sampling of GAS; 2. Severe malformations including congenital heart disease; 3. Congenital infections; 4. Infusion in the amniotic sac (diagnostic or therapeutic).

Design outcomes

Primary

MeasureTime frame
????;SEN, SPE, ACC, AUC of ROC;—

Countries

China

Contacts

Public ContactLi Zhankui

Northwest Women's and Children's Hospital

lzk5808@163.com+86 13772151229

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026