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Early Weaning of Preterm Newborn From Incubator to Cot at 1400 Grams

NCT04351425 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2020-04-17

No results posted yet for this study

Summary

Background: To maintain the body temperature of preterm newborns is one of the essential criteria for discharge from hospital.

Aim: we aimed to assess the feasibility and the safety of an early weaning protocol from incubator to unheated cot at 1400 g preterm newborns.

Methods: This was a randomized control trial with preterm neonates with birth weights \< 1400 g conducted at King Fahad Medical City, Riyadh, Saudi Arabia. We compared newborns weaned to cot at a weight of 1400 g to newborns weaned at a weight of 1600 g. The outcome was to assess the feasibility of the protocol in terms of temperature control and average weight gain.

Results: A total of 23 preterm neonates were recruited in this study. The baseline characteristics were similar except for the gestational age was higher in the newborns enrolled to 1400 g group. Early weaning was achieved in 100% of newborns without significant adverse effects on temperature stability or weight gain. Incidence of low and high temperatures per newborn and the average weight gain before and after transfer and after transfer were not different between the two groups.

Conclusion: Our results showed the feasibility and safety of 1400 g weaning protocol for preterm newborns, without any adverse effects or increasing the neonatal length of hospital stay. Further investigations in larger patient groups are recommended.

Conditions

  • Pre-Term
  • Body Temperature Changes
  • Transition
  • Patient Discharge
  • Length of Stay

Interventions

DEVICE

Weaning to crib

We weaned the infants into two groups. Group A, 1.6 kg

DEVICE

Weaning from incubator

We weaned the infants into two groups. group B, 1.4 kg

Sponsors & Collaborators

  • King Fahad Medical City

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-16
Primary Completion
2020-05-01
Completion
2020-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04351425 on ClinicalTrials.gov