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Benefits of the use of mothers milk for mouth care in sick babies

Expressed Breastmilk for Oral Care in Sick Neonates: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008010
Enrollment
128
Registered
2017-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: P84- Other problems with newborn Health Condition 2: P84- Other problems with newborn Health Condition 3: null- Sick preterm neonates and term mechanically ventilated neonates receiving intravenous fluids and/or orogastric feeds and are not expected to be fed orally in first 3 days of life.

Interventions

Intervention1: Expressed breastmilk: Eight hourly cleaning of oral mucosa will be done by sterile cotton buds soaked in fresh expressed breastmilk (EBM) of the biological mother followed by an instill

Sponsors

Sriparna Basu
Lead Sponsor
Priyanka Gupta Second Investigator
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Inborn sick preterm neonates and term mechanically ventilated neonates receiving intravenous fluids and/or orogastric feeds who are not expected to be fed orally in first 3 days of life.

Exclusion criteria

Exclusion criteria: 1.Positive sepsis screen at birth 2.Maternal HIV infection 3.Death of biological mother 4.Major congenital malformation

Design outcomes

Primary

MeasureTime frame
Combined incidence of nosocomial pneumonia and/or late-onset sepsisTimepoint: At day 28 life or at discharge from hospital, whichever is earlier

Secondary

MeasureTime frame
1.Difference in oral colonizer population with respect to oral care provided 2.Incidence of ventilator associated pneumonia and necrotizing enterocolitis 3.Procedure-related adverse effects 4.Days to achieve full feeds and regain birth weight 5.Exclusive breastfeeding rate at discharge 6.Overall mortality from any cause 7.Duration of hospital stay Timepoint: Till day 28 life or till discharge from hospital, whichever is earlier

Countries

India

Contacts

Public ContactSriparna Basu

Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University Varanasi, India

priyanka225gupta@gmail.com8005184382

Outcome results

None listed

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