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Mouth cavity application of mothers own milk for prevention of infection in low birth weight babies:A randomised controlled trial

Oral cavity application of mothers own milk for prevention of late onset sepsis in preterm very low birth weight neonates : A randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011326
Enrollment
110
Registered
2018-01-15
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: P369- Bacterial sepsis of newborn, unspecified Health Condition 2: P369- Bacterial sepsis of newborn, unspecified Health Condition 3: P00-P96- Certain conditions originating in the perinatal period Health Condition 4: null- LATE ONSET SEPSIS

Interventions

Intervention1: ORAL CAVITY APPLICATION OF MOHERS OWN MILK THRICE DAILY TILL THE BABY STARTS TAKING MOTHERS MILK DIRCTLY OR BY SPOON: Cleaning the oral cavity with motherâ??s own milk , once in every n

Sponsors

Smrati Jain
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Preterm 2 VLBW babies 3 Admitted in neonatology unit within 72 hours of birth will be enrolled

Exclusion criteria

Exclusion criteria: 1 Parents not giving consent 2 Major chromosomal/congenital anamoly 3 Contraindication to human milk exposure 4 H/o prior exposure of oral cavity to human milk 5 Mother unlikely to be able to provide colostrum or milk in first 3 days after delivery

Design outcomes

Primary

MeasureTime frame
To determine the effect of oral cavity application of motherâ??s own milk (MOM) for prevention of LOS in very low birth weight preterm neonates.LOS is said if neonate developing new clinical signs of sepsis after day 3 of life accompanied by a positive sepsis sscreen / positive blood or CSF or urine culture / pneumonia/ MeningitisTimepoint: Till discharge/death/LAMA—

Secondary

MeasureTime frame
To determine the effect of oral cavity application of motherâ??s own milk (MOM) in VLBW preterm neonates on exclusive breast feedingrate at dischargeTimepoint: Till discharge;To determine the effect of oral cavity application of motherâ??s own milk for prevention of BPDTimepoint: Till discharge/death/LAMA;To determine the effect of oral cavity application of motherâ??s own milk for prevention of IVHTimepoint: Till discharge/death/LAMA;To determine the effect of oral cavity application of motherâ??s own milk for prevention of MORTALITYTimepoint: Till discharge/death/LAMA;To determine the effect of oral cavity application of motherâ??s own milk for prevention of NECTimepoint: Till discharge/death/LAMA;To determine the effect of oral cavity application of motherâ??s own milk for prevention of ROPTimepoint: Till discharge/death/LAMA;To determine the effect of oral cavity application of motherâ??s own milk for prevention of VAPTimepoint: Till discharge/death/LAMA;To determine the effect of oral cavity application of motherâ??s own milk on the duration of mecahnical ventilationTimepoint: Till discharge/death/LAMA;To determine the effect of oral cavity application of motherâ??s own milk on the duration of oxygen therapyTimepoint: Till discharge/death/LAMA;To determine the effect of oral cavity application of motherâ??s own milk on the duration of Reaching full enteral feedsTimepoint: Till discharge/death/LAMA;To determine the effect of oral cavity application of motherâ??s own milk on the duration of TOTAL HOSPITAL STAYTimepoint: Till discharge/death/LAMA—

Countries

India

Contacts

Public ContactSmrati Jain

kgmu

mala_lko@yahoo.co.in9415470555

Outcome results

None listed

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