Study characteristics

Methods

Open‐label randomised controlled trial

Participants

A total of 122 neonates were enrolled in the study. 

Inclusion criteria

• All term live neonates, born through MSAF and non‐vigorous at birth, were included. Term babies were defined as those delivered at 37 or more weeks of gestation calculated using the last menstrual period or antenatal ultrasound. Non‐vigorous was defined as the presence of at least one of the following: heart rate < 100 beats/min, decreased muscle tone, and/or not breathing or crying (quote: NRP 2010).

Exclusion criteria

• Neonates with major congenital anomalies detected prenatally

Interventions

Endotracheal suction group (n = 61): non‐vigorous infants in the suction group were intubated and endotracheal suction was done using suction pressure of 80 to 100 mmHg. Suction pressure was applied continuously while withdrawing the endotracheal tube. If meconium was present and there was no bradycardia (heart rate < 60/min), the procedure was repeated again for a maximum of 2 suctions. After 2 endotracheal suctions, the baby was repositioned and oropharyngeal suction was given through first mouth and then nose, using suction catheter attached to wall suction device with the same pressure as for endotracheal suction, following which the baby was dried and the other steps of resuscitation were carried out. 

No endotracheal suction group (n = 61): only oro‐nasopharyngeal suction was done through first mouth and then nose using a suction catheter attached to wall suction device

Outcomes

The following outcomes were measured. All the outcomes are until the time of discharge from hospital. 

• Meconium aspiration syndrome defined as respiratory distress in an infant born through MSAF with characteristic radiological changes and whose symptoms cannot be otherwise explained

• Perinatal asphyxia defined as Apgar score < 6 at 5 minutes after birth with cord blood pH < 7 and a base deficit of > 12

• Pneumothorax

• Persistent pulmonary hypertension

• Need for mechanical ventilation

• Sepsis (culture‐positive)

• Pneumonia (secondary)

• Early neonatal mortality

• Duration of mechanical ventilation

• Duration of hospital stay

• Mild meconium aspiration syndrome

• Moderate meconium aspiration syndrome

• Severe meconium aspiration syndrome

• Duration of oxygen therapy

• Duration of respiratory distress

• In‐hospital mortality

• Hypoxic‐ischaemic encephalopathy

In addition, the following outcomes were measured at 9 months of age.

• Mental development index using Developmental Assessment Scale for Indian Infants (DASII)

• Psychomotor development index using Developmental Assessment Scale for Indian Infants (DASII)

Notes

Study was conducted in a tertiary care hospital of India from February 2013 to July 2014. 

This is a non‐funded investigator‐initiated trial.

No conflict of interest has been declared by the authors. 

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

The infant was randomised to either suction or no‐suction group using computer generated sequence.

Allocation concealment (selection bias)

Low risk

The infant was randomised to either suction or no‐suction group using computer generated sequence and sealed opaque envelopes opened immediately prior to birth.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Care providers were not masked to the study intervention. 

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcome assessors were not masked to the study intervention. 

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Complete outcome data are available for the primary outcomes of this review. 

Selective reporting (reporting bias)

Low risk

CTRI document is accessible at ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=6117&EncHid=&modid=&compid=%27,%276117det%27. But the protocol does not give a list of outcomes. However, all the important outcomes have been reported by the study. 

Other bias

Low risk

An academic trial, not funded, no other obvious risk of bias

Study characteristics

Methods

Open‐label randomised controlled trial

Participants

A total of 132 neonates were enrolled in the study. 

Inclusion criteria

• Non‐vigorous singleton neonates of gestational age ≥ 34 weeks delivered through MSAF

Exclusion criteria

• Major congenital malformations

• Maternal chorioamnionitis

Interventions

Endotracheal suction group (n = 66): endotracheal suctioning of meconium was done under direct laryngoscopy until no more meconium was retrieved from the trachea. Suction pressure used is not specifically mentioned, but authors state that it was according to NRP guidelines. Tracheal suction was preceded by oropharyngeal suction using a 12 to 14 Fr catheter. 

No endotracheal suction group (n = 66): after oropharyngeal suctioning of meconium, the remaining initial steps of resuscitation were completed without performing endotracheal suctioning.

Outcomes

The following outcomes were measured. All the outcomes are until the time of discharge from hospital. 

• Meconium aspiration syndrome defined as persistence of respiratory distress (respiratory rate > 60/min, chest wall retractions, grunting, or cyanosis) beyond 2 hours of age and characteristic radiological abnormalities of asymmetric patchy opacities, with or without hyperinflation in chest X‐ray.

• The requirement of delivery room resuscitation

• Need for respiratory support in NICU

• Mortality

• Duration of hospitalisation 

• Development of complications (perinatal asphyxia, pneumothorax, persistent pulmonary hypertension)

• Need for mechanical ventilation

• Sepsis (culture‐positive)

• Pneumonia (secondary)

• Early neonatal mortality

• Duration of mechanical ventilation

• Duration of hospital stay

• Duration of oxygen therapy

• Duration of respiratory distress

• Death (time not specified)

• Hypoxic‐ischaemic encephalopathy

• Need for any respiratory support

• In‐hospital mortality

• Shock

• Metabolic abnormalities

Notes

Study was conducted in a tertiary care hospital of India from 1 January 2014 to 30 September 2015. 

This is a non‐funded investigator‐initiated trial.

No conflict of interest has been declared by the authors. 

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random permuted blocks of 4, 6 and 8

Allocation concealment (selection bias)

Low risk

Serially numbered sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Care providers were not masked to the intervention. 

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcome assessors were not masked to the intervention. 

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Data about all the enrolled neonates are available.

Selective reporting (reporting bias)

Low risk

The trial protocol is available from a trial registry and all the important outcomes have been reported. 

Other bias

Low risk

An academic unfunded trial. No other obvious risk of bias. 

Study characteristics

Methods

Open‐label randomised controlled trial

Participants

A total of 175 neonates were enrolled in the study. 

Inclusion criteria

• Singleton

• Full‐term neonates (between 37 and 41 completed weeks) with cephalic presentation born through MSAF and who were non‐vigorous at birth

Exclusion criteria

• Major congenital malformations either diagnosed antenatally, or detected post‐birth

• Refusal to participate

Interventions

Endotracheal suction group (n = 87): after positioning of the neonate on the resuscitation trolley, oropharyngeal suction was done using a 12 to 14 Fr catheter followed by ET suction. Suction pressure is not mentioned but stated to be as per NRP guidelines. 

No endotracheal suction group (n = 88): only oropharyngeal suction was done using a 12 to 14 Fr catheter followed by initial steps and PPV if required.

Outcomes

The following outcomes were measured. All the outcomes are until the time of discharge from hospital. 

• Meconium aspiration syndrome was defined as respiratory distress with compatible chest X‐ray findings in a neonate born through MSAF whose symptoms cannot be otherwise explained.

• Perinatal asphyxia

• Pneumothorax

• Persistent pulmonary hypertension

• Need for mechanical ventilation

• Sepsis (culture‐positive)

• Pneumonia (secondary)

• Early neonatal mortality

• Duration of mechanical ventilation

• Duration of hospital stay

• Mild meconium aspiration syndrome

• Moderate meconium aspiration syndrome

• Severe meconium aspiration syndrome

• Duration of oxygen therapy

• Duration of respiratory distress

• Death (time not specified)

• Hypoxic‐ischaemic encephalopathy

• Need for any respiratory support

• In‐hospital mortality

Notes

Study was conducted in a tertiary care hospital of India from 1 May 2012 to 31 August 2013. 

This is a non‐funded investigator‐initiated trial.

No conflict of interest has been declared by the authors. 

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random sequence number using block randomisation with variable block size. 

Allocation concealment (selection bias)

Low risk

Serially numbered opaque brown sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Due to nature of the intervention, it is not possible to blind the healthcare personnel conducting resuscitation. However, the NICU care providers were masked to the study intervention.  

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessor were masked to the study intervention.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Outcomes of all the enrolled participants are reported. 

Selective reporting (reporting bias)

Low risk

The trial protocol is available in a trial registry and all the important outcomes have been reported. 

Other bias

Low risk

An academic unfunded trial. No other obvious risk of bias. 

Study characteristics

Methods

Open‐label randomised controlled trial

Participants

A total of 152 neonates were enrolled in the study. 

Inclusion criteria

• Singleton newborn infants born through MSAF who were non‐vigorous at birth

Exclusion criteria

• Vigorous at birth

• < 34 weeks' gestational maturity

• Having major congenital malformation

• Consent could not be obtained

Interventions

Endotracheal suction group (n = 75): non‐vigorous babies in intervention (ET suction) group were placed under radiant warmer immediately after birth, intubated under direct laryngoscopy and endotracheal suction was performed connecting the other end of the infant’s endotracheal tube with meconium aspirator which was already kept attached with the suction device (either wall‐mounted or infant suction device available at the newborn corner in the delivery room), set at 90 to 100 mmHg negative pressure. Suction was done while withdrawing the endotracheal tube keeping the suction pressure on, usually for 3 to 5 seconds. If meconium was recovered from the trachea and there was no severe bradycardia (heart rate < 60/min), the endotracheal suctioning procedure was repeated once again (a maximum of 2 suction attempts). Subsequent to ET suction, oropharyngeal and nasal suction was done using a suction catheter, followed by drying, stimulation if required, re‐positioning, and evaluation of breathing and heart rate. Further resuscitation was provided as required, in accordance with NRP guidelines, including intubation for positive pressure ventilation.

No endotracheal suction group (n = 77): infants allocated to the no‐ET suction group were immediately placed under warmer, oropharyngeal and then nasal suctioning were performed using 12–14 Fr suction catheters. Other components of initial steps and any further resuscitation were done as per NRP guidelines.

Outcomes

The following outcomes were measured. All the outcomes are until the time of discharge from hospital. 

• Meconium aspiration syndrome defined as early‐onset respiratory distress in a neonate born through MSAF whose symptoms could not be otherwise explained and who had characteristic radiological findings (coarse irregular infiltrates, hyperinflation, and or segmental or lobar atelectasis).

• Perinatal asphyxia

• Pneumothorax

• Persistent pulmonary hypertension

• Need for mechanical ventilation

• Sepsis (culture‐positive)

• Pneumonia (secondary)

• Early neonatal mortality

• Duration of mechanical ventilation

• Duration of hospital stay

• Mild meconium aspiration syndrome

• Moderate meconium aspiration syndrome

• Severe meconium aspiration syndrome

• Duration of oxygen therapy

• Duration of respiratory distress

• Hypoxic‐Ischaemic encephalopathy (moderate or severe)

• Death/left against medical advice

Notes

Study was conducted in a tertiary care hospital of India from September 2011 to August 2012. 

This is a non‐funded investigator‐initiated trial.

No conflict of interest has been declared by the authors. 

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

The random allocation sequence was computer generated

Allocation concealment (selection bias)

High risk

The list bearing the sequence of intervention was kept open, available to the team attending the delivery.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

The care providers were not masked to the study intervention. 

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessors were not aware of the study intervention. 

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All the outcomes for randomised study subjects have been reported.

Selective reporting (reporting bias)

Low risk

Authors have reported all the important outcomes.

Other bias

Low risk

An academic unfunded trial. No other obvious risk of bias.