A Model for Predicting Extubation Success in Premature Babies

NCT05081973 | Unknown

• 1 other identifier: MarmaraU_Neonatal
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 2

Brief Summary

Invasive mechanical ventilation is a life-saving treatment in critically ill newborns with respiratory failure. However, continuing this treatment for a long time may have negative consequences, especially bronchopulmonary dysplasia (BPD) secondary to mechanotrauma. For this reason, it is essential to terminate the mechanical ventilation treatment at the most appropriate time. About half of the extremely preterm babies may fail extubation even if the clinical criteria traditionally used for extubation are met. Unsuccessful extubation is associated with increased intraventricular bleeding, death, BPD, death or BPD, longer duration of ventilator support. When respiratory failure and lung pathologies of extremely preterm babies begin to improve, the target for mechanical ventilation should be early and successful extubation. Currently, the decision to extubate a preterm baby is primarily based on clinical judgment. Only a few studies that showed the low predictive value and limited utility using different measures have evaluated readiness for extubation. Lung ultrasonography (USG) is a noninvasive bedside technique that has been found useful for predicting the success of weaning from the ventilator in adults; however, very little data are available in neonates. In a recently published study, it was proposed an extubation readiness estimation tool based on clinical and demographic data of preterm babies who were attempted elective extubation. The researchers' hypothesis is that the use of a model based on extubation success scoring and lung USG scoring before extubation reduces the failure of the first extubation attempt in very low birth weight infants. The aim of the study is to evaluate the value of using an integrated model based on pre-extubation "extubation readiness predictor" and lung USG scoring to predict extubation success in preterm babies undergoing invasive mechanical ventilation.

Conditions

Neonatal Respiratory Failure; Invasive Mechanical Ventilation; Extubation Failure

Keywords

Neonate; Extubation Failure; Lung Ultrasonography Score; Extubation Readiness Estimator

Outcome Measures

Primary Outcomes (1)

• Extubation success

  Not to be reintubated for at least 5 days during the post-extubation period.

  For at least 5 days during the post-extubation period.

Secondary Outcomes (6)

• The incidence of morbidities related with prematurity.

  40 weeks' postmenstrual age.

• Length of stay in the hospital.

  40 weeks' postmenstrual age.

• Time elapsed on mechanical ventilation among survivors and the time taken with supplemental oxygen.

  40 weeks' postmenstrual age.

• Total noninvasive support time.

  40 weeks' postmenstrual age.

• Percentage of time spent below 90% and above 95% on the SpO2 histogram.

  During the first 5 days of the post-extubation period.

Study Arms (1)

Intubated preterm infants

Infants with a birth weight \< 1250 grams who have required endotracheal tube and mechanical ventilation within the first 7 days of life, and have been on an invasive mechanical ventilator for at least 48 hours, and have not completed 60 days after birth, and have met the traditional extubation criteria of the institution, and have been considered for elective extubation for the first time.

Other: A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography score

Interventions

A model for predicting extubation success based on extubation readiness estimator and lung ultrasonography score OTHER

Parameters to be recorded before and after extubation to create a "new dual extubation model" from all babies who met the extubation criteria included in the study: 1. "Lung ultrasound score": Lung ultrasound will be performed prior to the extubation and after the extubation. Lung aeration will be scored based on three chest areas for each side (upper anterior, lower anterior and lateral) and a score of 0 to 3 points will be given for each area (Total score ranges from 0 to 18 points). 2. "Probability of Successful Extubation": It will be calculated by extubation readiness estimator provided by the website named http://extubation.net/. This parameter will be calculated only 1 hour prior to the scheduled extubation time.

Intubated preterm infants

Eligibility Criteria

• Age: 48 Hours - 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All premature infants with planned extubation during the study period.

You may qualify if:

• Birth weight \<1250 gr
• Being intubated within the first 7 days of life and then followed on mechanical ventilation
• Being intubated for at least 48 hours
• Not completing the postnatal 60 days
• Meeting conventional clinical extubation criteria
• Having planned extubation for the first time
• Having no air leakage occurred
• Having no structural heart and lung disease
• Having no congenital and chromosomal anomalies
• Having an intact diaphragm
• Having no PVL, IVH (Grade 2 and above), HIE, meningitis or known CNS anomaly during extubation

You may not qualify if:

• Infants with a gestational age of 34 weeks or more
• Infants with unplanned and spontaneous extubation
• Infants who have tried extubation before
• Infants with hydrops fetalis
• Infants with chest deformities
• Infants with central respiratory failure (insufficient respiratory effort/control or continuous apneic)
• Infants who are neurologically depressed and do not have spontaneous breathing (hypocarbia due to hyperventilation, presence of severe sedation, use of neuromuscular drugs)
• In the presence of genetic or congenital anomalies (esophageal atresia, severe diaphragmatic hernia, diaphragm paralysis)
• Having phrenic nerve damage
• Presence of congenital myopathy
• Having any air leakage
• Having structural heart and lung disease
• Having no intact diaphragm
• Having PVL, IVH (Grade 2 and above), HIE, meningitis or known CNS anomaly during extubation

Sponsors & Collaborators

• Marmara University: lead
• Başakşehir Çam & Sakura City Hospital: collaborator

Study Sites (2)

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Related Publications (4)

• Shi Y, Muniraman H, Biniwale M, Ramanathan R. A Review on Non-invasive Respiratory Support for Management of Respiratory Distress in Extremely Preterm Infants. Front Pediatr. 2020 May 28;8:270. doi: 10.3389/fped.2020.00270. eCollection 2020.

  PMID: 32548084 BACKGROUND

• El Amrousy D, Elgendy M, Eltomey M, Elmashad AE. Value of lung ultrasonography to predict weaning success in ventilated neonates. Pediatr Pulmonol. 2020 Sep;55(9):2452-2456. doi: 10.1002/ppul.24934. Epub 2020 Jul 8.

  PMID: 32609928 BACKGROUND

• Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.

  PMID: 26237465 BACKGROUND

• Gupta D, Greenberg RG, Sharma A, Natarajan G, Cotten M, Thomas R, Chawla S. A predictive model for extubation readiness in extremely preterm infants. J Perinatol. 2019 Dec;39(12):1663-1669. doi: 10.1038/s41372-019-0475-x. Epub 2019 Aug 27.

  PMID: 31455825 BACKGROUND

Study Officials

• Eren Ozek

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Asli Memisoglu, MD

CONTACT

+905468807300; acinarmemisoglu@gmail.com

Eren Ozek, Prof.

CONTACT

+905324237568; ozekeren@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 18, 2021
• Study Start: April 20, 2021
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2024
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

TU (2)