A trial to study effect of stomach wash to prevent vomiting and abdominal distension in newborn born through meconium stained amniotic fluid.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/09/004988
• Date of registration: 08-09-2014
• Prospective Registration: No
• Primary sponsor: BPKoirala Institute Of Health SciencesDharan
• Public title: A trial to study effect of stomach wash to prevent vomiting and abdominal distension in newborn born through meconium stained amniotic fluid.
• Scientific title: ROLE OF GASTRIC LAVAGE IN VIGOROUS NEONATES BORN WITH MECONIUM STAINED AMNIOTIC FLUID: A HOSPITAL BASED STUDY
• Date of first enrolment: 22-02-2013
• Target sample size: 500
• Recruitment status: Not Applicable
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9876
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

Nepal

Contacts

• Name: DR.lokraj Shah
• Affiliation: B.P.Koirala institute of Health sciences,Dharan.

• Name: profDrGauri shankar shah
• Affiliation: B.P.Koirala institute of Health sciences,Dharan.

Key inclusion & exclusion criteria

Inclusion criteria: ï?? All vigorous neonates delivered through MSAF

ï?? Birth weight >=1800 g

ï?? Gestational age >=34 wk. (by New Ballard score)


Exclusion criteria: ï?? Non vigorous babies

ï?? Major congenital malformations

ï?? Neonates requiring Cardiopulmonary resuscitation at birth.



Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Normal saline: 10 ml/kg body weight of normal
saline for three times.
Intervention2: normal saline (10ml/kg): all vigorous neonates born through meconium stained amniotic fluid were divide into two groups as cases and control.
for cases: gastric lavage was done with 10ml/kg of normal saline for three times.
for control: gastric lavage was not done and subsequent effect was observed.


Intervention3: normal saline: for control: gastric lavage was not done and subsequent effect was observed.

Intervention4: normal saline at 10ml/kg for three times: for cases: gastric lavage was done with 10 ml/kg of normal saline for three times and subsequent effect on feeding intolerance was observed.
Intervention5: normal saline: cases: gastric lavage was done with normal saline at 10ml/kg for three times.
Intervention6: NIL: control: no intervention was done
Intervention7: NIL: NIL
Intervention8: normal saline: cases: gastric lavage was done with 10 ml/kg for three times.
Control Intervention1: NIL: control:no intervention was done and subsequent effect on feeding intolerance was observed.

Primary Outcome(s)

ï?? To find out the effect of gastric lavage in vigorous neonates born through meconium stained amniotic fluid in the form of feeding intolerance.

ï?? To compare incidence of feeding intolerance among the vigorous neonates born through meconium stained amniotic fluid (MSAF) who received gastric lavage and those who do not receive gastric lavage.

Timepoint: for first 48 hours neonates were monitored for evidence of feeding intolerance

Secondary Outcome(s)

complications of nasogastric suction-trauma,bleeding per nostrilTimepoint: 48 hours

Secondary ID(s)

NIL

Source(s) of Monetary Support

self (this study is a dissertation for post graduate resident )

Ethics review

Status: Approved
Approval date: 07/04/2013
Contact:

B.P.Koirala institute of health sciences