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