Outcome measures
Primary outcome measure:
Respiratory Distress:
(a)Tachypnoea with grunting, recession, or nasal flaring with diffuse
reticulogranular infiltrate on X-ray.
(b) Respiratory distress requiring the need for respiratory support by
72 hours of age and will consist of one or more of the following:
Requirement for intranasal oxygen for ≥ 4 hours
Requirement for Bubble Continuous Positive Airway Pressure.
Secondary outcome measures:
1. Transient tachypnoea of the new born: Respiratory distress resolved
within 72 hours of
life without diffuse reticulogranular infiltrate.
2. Admission into Special Care Baby Unit (SCBU)/Neonatal Intensive Care
Unit (NICU):
Stay in the SCBU/NICU for more than 12 hours within the first 72 hours
of life excluding admission after discharge. Period of observation is
not considered as admission. (All preterm neonates are routinely taken
to the SCBU for observation immediately after delivery.)
3. Apnoea: an unexplained episode of cessation of breathing for 20
seconds or longer, or
a shorter respiratory pause associated with bradycardia, cyanosis,
pallor, and/or marked
hypotonia.
4. Need for resuscitation at birth: Failure of the new born to cry
and/or initiate spontaneous breathing at birth. To be determined by
skilled birth attendants that conducts the delivery.
5. Neonatal hypoglycaemia: Blood glucose level less than 2.2mmol/L at 3
hours after delivery.
6. Neonatal sepsis: Hypothermia or pyrexia and clinical evidence of
sepsis in any organ/system.
7. Neonatal death.
8. Maternal sepsis: Clinical evidence of endometritis characterized by
pyrexia ≥ 38.0 sub-involution of uterus and foul-smelling lochia.