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.

Clinical presentation and chest X radiograph changes of BPD

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

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) The Denver Developmental Screening Test primarily assesses the development of infants and young children aged 0-6 years across four domains: Personal-Social, Fine Motor-Adaptive, Language, and Gross Motor. It does not provide a direct "score." Instead, by observing whether a child can complete age-appropriate items, the results are ultimately classified into four categories: Normal, Suspect, Abnormal, and Untestable.

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

Weight

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

Other outcomes

Sponsors and contacts

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