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Maintaining temperature of clinically well low birth weight babies in a low cost incubator â?? a preliminary study

Thermoregulation of stable preterm babies in a low cost infant incubator â?? A non-inferiority trial - infant incubator, neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/10/006316
Enrollment
96
Registered
2015-10-27
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: null- Preterm infants at post-menstrual age 32 to 36 weeks of gestation and of weight 1250 to 2250 grams Health Condition 2: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Low-cost Incubator: Low cost incubator (LCI) consists of disposable Cardboard Infant Chamber (dCIC), heating unit, 2 connecting pipes and infant trolley. dCIC of size 30" length, 14" w

Sponsors

Phoneix Medical systems Indian Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Method: Preterm infants at post-menstrual age 32 to 36 weeks of gestation and of weight 1250 to 2250 grams will be eligible for the study provided they donâ??t require any respiratory support or intravenous fluids and are eligible to shift from step down nursery to KMC ward as per unit protocol (KMC ward shift criteria). Infants eligible should have no ongoing problems and on full feeds, either by tube feeds or paladai feeds. Eligible babies will be recruited for study after informed consent from parents.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1.Infants having major anomalies or syndrome 2.Abnormal vitals during prior assessment will be excluded for study. 3.Infant requiring phototherapy for neonatal jaundice.

Design outcomes

Secondary

MeasureTime frame
(48 hours; 24 hours in Step down nursery, 24 hours in KMC ward)Timepoint: (48 hours; 24 hours in Step down nursery, 24 hours in KMC ward)

Primary

MeasureTime frame
1. Infants ability to maintain normal temperature (36.5 C to 37.4 C)in step-down nursery and in KMC ward)Timepoint: 24 hours in KMC ward 24 hours in Step down Nursery

Countries

India

Contacts

Public ContactDr Ashok C

SRI RAMACHANDRA UNIVERSITY

drbinusss@gmail.com45928611

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 24, 2026