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Benifits of giving albumin in abdominal surgeries in newborns.

Albumin supplementation in neonates undergoing emergency abdominal surgeries. A Randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027632
Enrollment
200
Registered
2020-09-07
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: K00-K95- Diseases of the digestive system

Interventions

Intervention1: Albumin supplementation: albumin 10% infusion IV 0.5 gm/kg/ day over 4 hours. Control Intervention1: Saline as placebo: To compare with Albumin supplementation in neonates undergoing

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All neonates undergoing abdominal surgery(All GIT atresias, malrotation, gastroschisis, exomphalos minor, NEC, bowel perforations) 2. Gestation > 32 weeks

Exclusion criteria

Exclusion criteria: 1. Acute kidney injury ( Serum creatinine > 1.5) or oliguria (urine output 2. Ventilated neonates requiring Fio2 > 60%. 3. Congestive cardiac failure 4. CKD patients 5. Colostomy for anorectal malformations.

Design outcomes

Primary

MeasureTime frame
Decrease in surgical complication rate in neonates receiving albumin infusion as compared to the placebo group.Timepoint: Discharge/ Death

Secondary

MeasureTime frame
1. Incidence of sepsis in both the groups 2. Incidence of mortality in both the groups. 3. Comparison of biochemical parameters- Blood urea nitrogen levels , serum creatinine, Serum albumin levels (g/l), Serum prealbumin and sodium between two groups. 4. Comparison of ventilation days and inotrope requirement in both the groups. Timepoint: At discharge/ Death

Countries

India

Contacts

Public ContactDr SHIVANI DOGRA

PGIMER CHANDIGARH

ajshukla2006@yahoo.com9654217383

Outcome results

None listed

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