The study to compare two ways of helping premature babies stop using Non -invasive breathing support . ONE METHOD will be gradual reduce the support while the other method would be to stop the support suddenly .

Sudden versus Gradual Weaning from NIV support in preterm neonates :- A Randomized Controlled Trial . - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/069733

Enrollment

160

Registered

2024-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: SUDDEN WEANING of NIV Support in preterm neonate of gestation 28 to 36 week .: In sudden weaning protocol ( GROUP A) we will wean of the NIV Support within 2hrs by using first oxygen

Eligibility

Inclusion criteria

Inclusion criteria: All preterm neonates (28 to 36 week) on NIV Support and met the weaning readiness criteria . 1. Clinically stable neonate on NIV,PEEP of less than equal to 6cm H2O,Fio2 less than equal to 0.35percent, Maintaining Spo2 90-95percent for a minimum of 12 hours. 2. Normal work of breathing:no persistent tachypnea (more than 60 breaths for more than 2hr ),no marked retractions . 3. Hemodynamically stable . 4.NO APNEA associated with bradycardia or cyanosis with more than 2 episode in 12hr or more than 3 in 24hr with at least one requiring bag and mask ventilation . 5.Not currently treated for Patent ductus arteriosus. 6.Tolerated time off NIV during nursing cluster care for up to 5 to 10 minutes. 7. Pip of less than equal to 15 cm H20 and backup respiratory rate of less than equal to 50 percent of total respiratory rate. 2.

Exclusion criteria

Exclusion criteria: Preterm neonates with chromosomal defects and severe congenital anomalies including congenital heart disease , neurological malformations , chest wall or airway abnormalities and lung hypoplasia .

Design outcomes

Primary

Measure	Time frame
Proportion of preterm neonates successfully weaned in the first attempt of weaning in each group.Timepoint: Randomization to off oxygen for 3 days	—

Secondary

Measure	Time frame
1. Mean post -menstrual age at the time of successful wean in both the group. 2. Mean weight at time of successful wean in both the group. 3.Total duration of NIV Support in successfully weaned preterm neonates of each group . 4.Length of stay (LOS) in NICU in successfully weaned preterm neonates of each group .Timepoint: 1.Randomization to off oxygen for 3 days . 2.Randomization to off oxygen for 3 days. 3.Date from patient require NIV to Off NIV support. 4 Date of admission to Date of discharge/death/lama/abscond/refered to another hospital.	—

Measure

Time frame

1. Mean post -menstrual age at the time of successful wean in both the group. 2. Mean weight at time of successful wean in both the group. 3.Total duration of NIV Support in successfully weaned preterm neonates of each group . 4.Length of stay (LOS) in NICU in successfully weaned preterm neonates of each group .Timepoint: 1.Randomization to off oxygen for 3 days . 2.Randomization to off oxygen for 3 days. 3.Date from patient require NIV to Off NIV support. 4 Date of admission to Date of discharge/death/lama/abscond/refered to another hospital.

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Countries

India

Contacts

Public ContactDr Varsha Jain

University college of medical sciences and Guru tegh bahadur Hospital , Delhi

vastava0309@yahoo.in9718502133

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026