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

April 15, 2020 updated by: Abdulrahman Al-Matary, King Fahad Medical City

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Introduction To discharge a preterm newborn after staying in neonatal intensive care unit (NICU) is a multifactorial decision. According to the American Academy of pediatrics guidelines of the physiologic competencies for hospital discharge of the high-risk neonate including preterm ones, are sufficient oral feeding and mature respiratory control, and finally the ability to maintain a normal body temperature in an unheated open bed (1). These mostly are achieved between 36 and 37 weeks' postmenstrual age (2-4).

    Shortening the period of a hospital stay, it could be beneficial to decrease the emotional stress resulted from the separation between the mother and the newborn and parents; furthermore, it may reduce the hospital-acquired co-morbidities as sepsis and surgical needs (5) and accordingly reduce the economic burden on the society.

    The timing to wean from the incubator is crucial since the immaturity of preterm newborn's thermoregulatory mechanisms which could affect weight gain as an attempt to maintain body temperature, achieving full feeding volume, and as a result could delay discharge from hospital (6, 7). The target weight for incubator weaning varies widely among NICUs. The common usual practice is between of 1700-1800 g, and it is generally based on the professional experience and judgment (8, 9).

    In 2010, a Cochrane Review assessed transferring preterm infants from incubator to open bed at a lower body weight (˂1700 g) by comparing to a higher body weight (˃ 1700 g). The review showed that preterm newborns can be transferred to open beds at 1600 g without adverse effects on temperature stability in terms of return to incubator or daily weight gain (10). A multicenter trial achieved the same result (11).

    Moreover, there are few studies showed that infants can be successfully transferred into cots at weights down to 1500 g (9, 12). A pilot study carried out stepwise four cohort trials of newborn's transfer from incubators to open beds at 1800 g, then at 1700 g, then at 1600 g and then finally at 1500 g (13). It demonstrated that there were no significant differences between the four cohorts in maintain body temperature after incubator weaning.

    The primary outcome of this study was to evaluate the feasibility and safety of incubator weaning for medically stable preterm neonates to unheated open cot at a body weight of 1400 g in terms of daily weight gain and temperature control. Newborns in the same study period were compared to a control group weaned at body weight of 1600 g.

  2. Subjects and Methods:

2.1. Study design A prospective randomized clinical trial was conducted at NICU at King Fahad Medical City, Riyadh, Saudi Arabia. Preterm newborns admitted to NICU fulfilling items in inclusion and exclusion criteria during the period from August 2017 to October 2018 were included into the study.

All eligible newborns were randomized into two groups to be weaned at 1,400 or at 1,600 g in a 1:1 ratio, using random block of 4. Newborns were eligible if body weight less than 1400 g, they were at least 5 days of age at the time of transferring to cot, they fed at least 60 ml/kg/day at the time of transferring to cot, and they are medically stable with no significant apnea or bradycardia, no ventilator support, no phototherapy and not having a major congenital abnormality. Newborns were excluded if they didn't fulfill the above criteria or unlikely to reach the target weight within 7 days.

2.2. Procedures Nursery temperatures were adjusted at 24-28 ◦c from birth to cot. The subjects were dressed in a hat, one vest and two wraps. Then, they were randomly assigned to either study group or control group. Infants were weighed naked daily. In the study group, the newborns were transferred to cot at a weight of 1400 to 1499 g and in the control group; they were transferred at a weight of 1600 to 1699 g. In the first day in the open cot, they were not bathed.

2.3. Data Collected

  • Baseline characteristics as birth weight, gestational age (GA), gender, age in days in the transfer day, body weight and GA in the transfer day.
  • Relevant data from to incubator weaning
  • After transfer, hourly axillary temperatures were taken until two consecutive readings between 36.4 and 37.1 °C. Then, temperatures were taken every 3 hours with each feed for at least 72 hours. After that, temperatures were taken four times a day minimum until discharge. If the axillary temperature was ˂36.4°C, thus an additional wrap was added. If the temperature was still low for an hour later, then the infant was returned to the incubator. Meanwhile, if the temperature was more than 37.1°C, a wrap was reduced.
  • No of infants who failed to be transferred to cot. Failure of transfer is defined as the inability to maintained body temperatures above 36.4°C in a two consecutive axillary temperatures in a cot despite of adding covering.
  • For infants who remained in an open crib, the rate of weight gain calculated every day over the week before and after transfer. In the discharge day, age in days after transfer to discharge date, WT and GA.

2.4. Statistical methodology: Data were statistically described in terms of mean ± SD for continuous data and in frequencies (number of cases). For comparative purposes between groups in all continuous data, independent t-test or Mann Whitney t test was adopted. X2-square and fisher test were used for assessing association in categorical data.. P values less than 0.05 were considered statistically significant. All statistical calculations were done using computer program IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 21 for Microsoft Windows.

2.5. Ethical considerations: Due to safety concerns, the study was carried out in two steps. Initially, we started infants' weaning with the approved weaning weight at1500 grams. A total of 19 preterm infants were randomized in two groups. Both groups were weaned to cot with a 100% success rate without any complications. Afterwards, the study was approved by the local Ethics Committee to start the second phase of the study at weaning weight of 1400 g. The parents were all directly contacted and agreed in writing informed consent.

Study Type

Interventional

Enrollment (Anticipated)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: study group
study group will be shifted from incubator to an unheated open cot a weight of 1400 grams
Device: Weaning to crib
We weaned the infants into two groups. Group A, 1.6 kg
Other Names:
  • Giraffe GELV61778 General Electric Company
Device: Weaning from incubator
We weaned the infants into two groups. group B, 1.4 kg
Other Names:
  • Giraffe GELV61778 General Electric Company
ACTIVE_COMPARATOR: control group
control group will be shifted from incubator to an unheated open cot at a weight of 1600 grams
Device: Weaning to crib
We weaned the infants into two groups. Group A, 1.6 kg
Other Names:
  • Giraffe GELV61778 General Electric Company
Device: Weaning from incubator
We weaned the infants into two groups. group B, 1.4 kg
Other Names:
  • Giraffe GELV61778 General Electric Company

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
daily weight gain
Time Frame: 1 month
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
Time Frame: 1 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Fahad Medical City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 16, 2020

Primary Completion (ANTICIPATED)

May 1, 2020

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

April 15, 2020

First Posted (ACTUAL)

April 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If this study plan goes successfully through, we shall continue the study. Basically, there is no concern in regards to the safety of the participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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