IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 10
SponsorInternational Peace Maternity and Child Health Hospital

About this trial

It is intended to examine the efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms. 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 between 25 weeks and 29 weeks + 6 days

Admission within 24 hours after birth.

Clinical symptoms and chest X-ray results show a highly suspicion of BPD (Clinical symptoms and chest X-ray changes of BPD).Clinical symptoms develop in several days or weeks after birth, including respiratory symptoms and signs such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence (increased oxygen concentration and assisted ventilation) .One of the following signs present in chest X-ray: lung texture thickening or ground glass opacity in early stage, diffuse lung texture blurred, lung hyperinflation, shadow of linear density increased, and shadow of triangular density increased under the pleura.

A normal full-term newborn without a history of severe lung diseases, birth asphyxia, hypoxic-ischemic encephalopathy or other conditions that may affect the development of the respiratory, nervous and other systems.

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

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

Trial outcomes

Primary outcomes

1

Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA

According to the diagnosis criteria published by National Institute of Child Health and Human Development in 2018, a premature infant (\<32 weeks'gestational age) with BPD has persistent parenchymal lung disease, radiographic confirmation of parenchymal lung disease, and at 36 weeks PMA requires 1 of the following FiO2 ranges/oxygen levels/O2 concentrations for ≥3 consecutive days to maintain arterial oxygen saturation in the 90%-95% range. (We have rephrased the title and description to better recapitulate the original intent of the IRB-approved protocol)

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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