Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05511233 |
Other study ID # |
2022 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2023 |
Est. completion date |
September 30, 2024 |
Study information
Verified date |
January 2023 |
Source |
Izmir Katip Celebi University |
Contact |
Esra ARDAHAN AKGÜL, Asst. Prof. |
Phone |
+00902323293535 |
Email |
esra.ardahan[@]ikcu.edu.tr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Aim: To determine whether the enteral feeding time and the type of the nutrient (according to
the ERAS Recommendations) have any effect on LoS, complications, body weight gain, time until
oral feeding, and time until first stool who have undergone intestinal surgery.
Design: A blinded, retrospective, randomized controlled trial. Setting: One-centred.
Participants: Newborns who had intestinal surgery in the Ege University Faculty of Medicine
Hospital Neonatal Surgery Intensive Care Unit and whose records can be accessed
retrospectively from the electronic health records will be included. Those whose early
enteral feeding initiation is contraindicated will not be included in the study.
Description:
Every year, approximately 1.7 million children, most of them in low- and middle-income
countries, are deprived of safe and evidence-based surgical and anaesthesia practices in the
world, resulting in lifelong disability or mortality. The care of children who have undergone
surgery, and especially newborns, has different physiological and sociological difficulties
compared to adults. Newborns make up a particularly complex patient population due to their
blood volume, temperature imbalance, immature immune systems, nutritional needs for growth
and recovery, and inability to communicate. Therefore, guidelines have been developed to
improve perioperative care and recovery through research, education, supervision and
implementation of evidence-based practices in newborns. One of these guidelines is
Perioperative Care in Neonatal Intestinal Surgery by Enhanced Recovery After Surgery® (ERAS)
Society. In this guideline, there are recommendations on surgical practices, antimicrobial
prophylaxis, hypothermia, perioperative fluid management, perioperative analgesia, optimal
haemoglobin level, perioperative communication, postoperative nutritional care, mucous
fistula refeeding and parental involvement. Among these recommendations, the initiation of
early feeding (in the first 48 hours) is one of the core elements of nursing care. In
patients who are not contraindicated such as necrotizing enterocolitis and volvulus, early
feeding has effects on length of hospital stay (LoS), risk of wound infection, and increasing
C-reactive protein levels. Although studies support this recommendation, different clinical
conditions may require a delay in feeding, therefore, evidence for this recommendation was
found to be weak in the guideline. Studies in different populations are needed to increase
the strength of this recommendation. Also, the nutrient content is as important as the time
of initiation of feeding, because thanks to its anti-infectious effect, it reduces the
incidence of respiratory and gastrointestinal tract infections and necrotizing enterocolitis.
Some studies have also shown neurodevelopmental advantages and a reduced incidence of
metabolic disease. In addition, it has been determined that breast milk provides proper
growth in newborns who have undergone surgery and prevents postoperative complications in
babies who have had heart surgery. Therefore, in the ERAS protocol, it is recommended that
the first preferred nutrient is breast milk. In the postoperative period, feeding
intolerances can be seen in newborns as a complication because due to the operation, a
dilated proximal segment may occur with hypoplasia of the smooth muscle or enteric nervous
system, which leads to feeding intolerance. To prevent this complication, it is considered
appropriate to use breast milk, which is a nutrient with high tolerability and can support
intestinal adaptation thanks to its barrier function, probiotics and immunoglobulins it
contains.
Design: A blinded, retrospective, randomized controlled trial. Setting: One-centred.
Participants: Newborns who had intestinal surgery in the Ege University Faculty of Medicine
Hospital Neonatal Surgery Intensive Care Unit and whose records can be accessed
retrospectively from the electronic health records will be included. Those whose early
enteral feeding initiation is contraindicated will not be included in the study.
Groups:
ERAS Group: Newborns who had breastmilk within the first 48 hours in the postoperative period
will be in the ERAS group.
Control Group: Newborns who do not receive breast milk in the first 48 hours of the
postoperative period will be in the control group.
Variables: The dependent variables of this study are the length of hospital stay, time until
full feed (120 ml/kg/day), time until first oral feeding, time until first stool, body weight
gain, feeding intolerance (abdominal distention and repeated vomiting-more than three times a
day) and Accordion Severity Grading System of Surgical Complications Score. The independent
variables of this research are the type of the surgery, enteral feeding time and the type of
the nutrient.
Randomization: It was found that 80 newborns met the inclusion criteria for the control
group. To randomly select 21 of these 80 newborns Random Integer Generator on www.random.org
will be used.
(https://www.random.org/integers/?num=21&min=1&max=80&col=1&base=10&format=html&rnd=new) It
was found that 65 newborns met the inclusion criteria for the ERAS group. To randomly select
21 of these 65 newborns Random Integer Generator on www.random.org will be used
(https://www.random.org/integers/?num=21&min=1&max=65&col=1&base=10&format=html&rnd=new). No
stratification will be used in randomization.
Main Outcomes and Measures: The main outcomes of this study are LoS, time until full feed
(120 ml/kg/day), time until first oral feeding, time until first stool, body weight gain,
feeding intolerance (abdominal distention and vomiting). The secondary outcome is the
Accordion Severity Grading System of Surgical Complications Score20.
Accordion Severity Grading System of Surgical Complications Score: It was developed by
Strasberg in 2009. In this scoring, the frequency of complications is evaluated under the
sub-headings of mild complications, moderate complications, severe complications requiring
intervention with or without anaesthesia, organ system failure or death.
Statistics: The minimum sample size in each group was considered 21 and a total of 42 using a
power formula with a = 0.05, power of 95%, and 0.50 effect size 1.06. To calculate the sample
size G*Power 3.1.9.2 programme was used. In determining the differences between the groups in
terms of the main outcomes, the Mann-Whitney U or Chi-square tests will be used since they
are independent groups.