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.
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.
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