Arterial carbon dioxide level after brief ventilation using self inflating bag versus T- piece resuscitator following surfactant therapy

To compare the arterial PCO2 level after brief ventilation using self inflating bag versus T- piece resuscitator post surfactant instillation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/08/006067

Enrollment

Registered

2015-08-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: null- Preterm infants with respiratory distress syndrome and FiO2 requirement of 30% needing first dose of surfactant admitted to Surya ChildrenÃ¢â?¬â?¢s Hospital NICU

Interventions

Intervention1: T -piece resuscitator(TPR): T- piece resuscitator (TPR) will be used for intermittent positive pressure ventilation during surfactant administration Control Intervention1: Self inflatin

Eligibility

Inclusion criteria

Inclusion criteria: preterm infants with respiratory distress requiring 1st dose of surfactant

Exclusion criteria

Exclusion criteria: Antenatally diagnosed congenital heart disease such as complex cyanotic heart disease Infants who have received first dose of surfactant prior to transfer to the hospital

Design outcomes

Primary

Measure	Time frame
Mean change in arterial CO2 pre and post surfactant administration in SIB (Self inflating bag) versus TPR (T-Piece Resuscitator) group Timepoint: 30 minutes	—

Secondary

Measure	Time frame
Mean PaCO2 six hours post surfactant administration (mm Hg)Timepoint: 6 hours;Mean PaO2 six hours post surfactant administration (mm Hg)Timepoint: 6 hours;Requirement of assisted ventilation (%)Timepoint: 1st week of life;Type of respiratory support required (%)Timepoint: 1st week of life;Duration of respiratory support (days)Timepoint: 28 days;Duration of oxygen therapy (days)Timepoint: 28 days;Duration of hospital stay (days)Timepoint: at the time of discharge from NICU;Incidence of air leak/Pneumothorax (%)Timepoint: 28 days;Incidence of Intraventricular Hemorrhage -IVH and Periventricular leucomalacia PVL (%)Timepoint: 28 days;Incidence of Retinopathy of prematurity ROP (%)Timepoint: at the time of discharge from NICU;Incidence of Necrotising Enterocolitis -NEC (%)Timepoint: 28 days;Incidence of Bronchopulmonary Dysplasia BPD (%)Timepoint: at 36 weeks of post conceptional age	—

Measure

Time frame

Mean PaCO2 six hours post surfactant administration (mm Hg)Timepoint: 6 hours;Mean PaO2 six hours post surfactant administration (mm Hg)Timepoint: 6 hours;Requirement of assisted ventilation (%)Timepoint: 1st week of life;Type of respiratory support required (%)Timepoint: 1st week of life;Duration of respiratory support (days)Timepoint: 28 days;Duration of oxygen therapy (days)Timepoint: 28 days;Duration of hospital stay (days)Timepoint: at the time of discharge from NICU;Incidence of air leak/Pneumothorax (%)Timepoint: 28 days;Incidence of Intraventricular Hemorrhage -IVH and Periventricular leucomalacia PVL (%)Timepoint: 28 days;Incidence of Retinopathy of prematurity ROP (%)Timepoint: at the time of discharge from NICU;Incidence of Necrotising Enterocolitis -NEC (%)Timepoint: 28 days;Incidence of Bronchopulmonary Dysplasia BPD (%)Timepoint: at 36 weeks of post conceptional age

—

Countries

India

Contacts

Public ContactDr Amrit Jeevan

Surya Childrens Hospital

dramritjeevan@gmail.com9930095491

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026