Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorUniversity of California, San Diego

About this trial

Preterm neonates born at less than 30 weeks' gestation are commonly maintained on invasive or non-invasive respiratory support to facilitate gas exchange. While non-invasive respiratory support (NIS) can be gradually reduced over time as the infant grows, most weaning strategies often lead to weaning failure. This failure is evidenced by an increase in significant events such as apneas, desaturations, and/or bradycardias, increased work of breathing, or an inability to oxygenate or ventilate, resulting in escalated respiratory support. Although the optimal approach to weaning NIS remains uncertain, neonatal units that delay Continuous Positive Airway Pressure (CPAP) weaning until 32-34 weeks corrected gestational age exhibit lower rates of chronic lung disease. Therefore, the investigators aim to compare the duration on respiratory support and oxygen exposure in infants born at less than 30 weeks' gestational age who undergo a structured weaning protocol that includes remaining on CPAP until at least 32-34 weeks corrected gestational age (CGA). The hypothesis posits that preterm infants following a structured weaning protocol, including maintaining CPAP until a specific gestational age, will demonstrate lower rates of weaning failure off CPAP (defined as requiring more support and/or experiencing increased stimulation events 72 hours after CPAP weaning) than those managed according to the medical team's discretion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All infants admitted to the NICU at Jacobs, Rancho Springs, Scripps La Jolla, Rady Children's Hospital, or Palomar born at < 30 weeks CGA

Informed parental consent obtained

Disqualifiers

Declined or unable to give informed consent

Infants with known congenital anomalies or complications that require long term support (pulmonary hypoplasia, airway defects, genetic syndromes, necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP), anything surgical)

Intubated for over 4 weeks of life (28 days)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standardized/structured CPAP weaning protocol

    Other intervention

    Standardized/structured CPAP weaning protocol up to 32 or 34 weeks gestational age (GA) (based on GA at birth) for infants born at less than 30 weeks GA.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Standardized NIS WeanExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of participants with CPAP/NIS weaning failure

Number of participants needing more support and/or with increased sleep stimulation events after weaning off of CPAP/NIS.

Time frame
72 hours after weaning off of CPAP

Secondary outcomes

1

Number of stimulation events per 24 hours

Significant results are defined as: apnea (pause in respiration for greater than 20 seconds), and/or bradycardia (heart rate \< 100) and/or desaturations (pulse oximetry saturations \< 85%) not associated with feeds.

Time frame
Through study completion, an average of 4 months
2

Length of hospital stay

Length of hospital stay prior to discharge home, including days at transfer hospital (if applicable).

Time frame
Through study completion, an average of 4 months
3

Rate of bronchopulmonary dysplasia

Bronchopulmonary dysplasia (BPD) assessed at 36 weeks gestational age.

Time frame
Through study completion, an average of 4 months
4

Use of postnatal steroids

Use of postnatal steroids during the NICU course

Time frame
Through study completion, an average of 4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

Rady Children's Hospital, San Diego

Collaborator