Length of Stay Clinical Trial
Official title:
Feasibility and Safety of Earlier Weaning of Preterm Newborn From Incubator to Cot at 1400 Grams
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.
Status | Not yet recruiting |
Enrollment | 61 |
Est. completion date | June 30, 2020 |
Est. primary completion date | May 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 23 Weeks to 34 Weeks |
Eligibility |
Inclusion Criteria: - Clinical weight less than 1.5 kg at birth - Clinically stable - No cardio or respiratory support - Reached 2/3 of his/her enteral feeding Exclusion Criteria: - IUGR - Clinical unstable - On cardio or respiratory support - Dysmorphic |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
King Fahad Medical City |
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | daily weight gain | newborns were weighed naked daily as a routine NICU practice using electronic scales. The rate of weight gain was calculated as grams/kilogram per day over the week before and after transfer. | 1 month | |
Primary | temperature control | Hourly axillary temperature was taken until two consecutive readings of between 36.4 and 37.1 C, after which temperatures were taken 3 times with each feed until at least 72 hours after transfer and after that a minimum of four times a day until discharge. If the axillary temperature is less than 36.4?C, an additional wrap was added. If the temperature remained low, an hour later, the newborn was returned to an incubator. Failure to transfer was defined as the inability to maintained body temperatures in a cot despite additional covering, with two consecutive axillary temperatures below 36.4 ?C, one hour apart. If the temperature more than 37.1C°, the wraps were reduced accordingly.temperature | 1 month |
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