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

NCT04351425 | Unknown DMC FDA Device

• 1 other identifier: 17-048
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Preterm; Patient discharge; Length of stay; Low birth weight

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

study group

EXPERIMENTAL

study group will be shifted from incubator to an unheated open cot a weight of 1400 grams

Device: Weaning to crib; Device: Weaning from incubator

control group

ACTIVE COMPARATOR

control group will be shifted from incubator to an unheated open cot at a weight of 1600 grams

Device: Weaning to crib; Device: Weaning from incubator

Interventions

Weaning to crib DEVICE

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

Also known as: Giraffe GELV61778 General Electric Company

control group; study group

Weaning from incubator DEVICE

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

Also known as: Giraffe GELV61778 General Electric Company

control group; study group

Eligibility Criteria

• Age: 23 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Clinical weight less than 1.5 kg at birth
• Clinically stable
• No cardio or respiratory support
• Reached 2/3 of his/her enteral feeding

You may not qualify if:

• IUGR
• Clinical unstable
• On cardio or respiratory support
• Dysmorphic

Sponsors & Collaborators

• King Fahad Medical City: lead

Related Publications (18)

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  PMID: 8390644 BACKGROUND

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  PMID: 25276681 BACKGROUND

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  PMID: 4192368 BACKGROUND

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  PMID: 10023375 BACKGROUND

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  PMID: 19945108 BACKGROUND

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  PMID: 3225660 BACKGROUND

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  PMID: 21901688 BACKGROUND

• Shankaran S, Bell EF, Laptook AR, Saha S, Newman NS, Kazzi SNJ, Barks J, Stoll BJ, Bara R, Gabrio J, Childs K, Das A, Higgins RD, Carlo WA, Sanchez PJ, Carlton DP, Pavageau L, Malcolm WF, D'Angio CT, Ohls RK, Poindexter BB, Sokol GM, Van Meurs KP, Colaizy TT, Khmour A, Puopolo KM, Garg M, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health, and Human Development Neonatal Research Network. Weaning of Moderately Preterm Infants from the Incubator to the Crib: A Randomized Clinical Trial. J Pediatr. 2019 Jan;204:96-102.e4. doi: 10.1016/j.jpeds.2018.08.079. Epub 2018 Oct 15.

  PMID: 30337189 BACKGROUND

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  PMID: 8057186 BACKGROUND

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  PMID: 16398870 BACKGROUND

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  PMID: 20696729 BACKGROUND

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  PMID: 22364676 BACKGROUND

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  PMID: 7243513 BACKGROUND

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  PMID: 24886971 BACKGROUND

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  PMID: 19461592 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Body Temperature Changes

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Abdulraham AM Al-Matary, MD

CONTACT

00966500333362; aalmatary@kfmc.med.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants: randomly selected infants, group 1 less than 1400 kg, group 2 more than 1600 kg
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: April 17, 2020
• Study Start: April 16, 2020
• Primary Completion: May 1, 2020
• Study Completion: June 30, 2020
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share