Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-10
SponsorInternational Peace Maternity and Child Health Hospital

About this trial

It is intended to examine the short-term and long-term efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms born at 28 weeks and below. Participants will received continuous infusion IVIG 1 g/kg/day for the first 2 days, 0.5 g/kg/day for next 3 days (total does 3.5 g/kg), repeatable if necessary.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Gestational age ≤ 28 weeks + 6 days

Admission within 24 hours after birth.

Infants show a suspicion of BPD, the diagnosis is suspected based on the following clinical manifestations and chest X-ray findings.

Disqualifiers

Major congenital anomalies(e.g., congenital heart disease, congenital craniocerebral deformity, congenital structural abnormality of respiratory system, congenital hereditary metabolic disease)

Chromosomal defects (e.g., trisomy 13, 18, 21)

Severe intracranial hemorrhage

Multiple organ failure

Trial design

Design model

Single group

Treatments tested in this trial

  • intravenous immunoglobulin

    Drug

    1 g/kg/day for the first 2 days, 0.5 g/kg/day for next 3 days (total does 3.5 g/kg), repeatable if necessary.

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: IVIGExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

rate of BPD and severity classification at postmenstrual age (PMA) 36 weeks

Diagnostic Criteria for BPD: The 2018 National Institute of Child Health and Human Development (NICHD) diagnostic criteria will be applied, defining BPD in preterm infants born at \<32 weeks GA as the presence of radiographically confirmed persistent parenchymal lung disease with a requirement for supplemental oxygen support (for ≥3 consecutive days) at PMA 36 weeks to maintain arterial oxygen saturation in the range of 90-95%.

Time frame
36 weeks of postmenstrual age

Secondary outcomes

1

duration of respiratory support

Defined as cumulative days on assisted ventilation, support with oxygen, or both

Time frame
until first discharge home or 36 weeks PMA
2

Preterm birth complications

Complications of preterm birth include retinopathy of prematurity, intraventricular hemorrhage, necrotizing enterocolitis, and septicemia et.al.

Time frame
until first discharge home or 36 weeks PMA
3

Neurodevelopmental assessment

Neurodevelopmental testing (e.g., Denver Developmental Screening Test)

Time frame
Corrected age/ chronological age of 6 months, 1 year, and 2 years
4

Pulmonary function testing

Normal/Abnormal. Pulmonary function testing includes the following parameters: Breathing Frequency (BF), Inspiratory Time (TI)/ Expiratory Time Ratio (TE), Tidal Volume (VT), Time to Peak Tidal Expiratory Flow (TPTEF), Volume to Peak Tidal Expiratory Flow (VPTEF), etc. The determination of abnormal lung function in infants is primarily relies on the analysis of TPTEF/TE and VPTEF/VE ratios, the shape of the TBFV (Tidal Breathing Flow-Volume) loop, and the integration of clinical presentation.

Time frame
Corrected age/ chronological age of 6 months, 1 year, and 2 years

Other outcomes

Sponsors and contacts

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