Preterm Infant Clinical Trial
Official title:
Early Versus Delayed Enteral Feeding for Achieving Full Feeding in Preterm Growth-Restricted Infants: A Randomized Clinical Trial
Verified date | February 2018 |
Source | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The introduction of enteral feeds for preterm, growth restricted infants are often delayed
due to concern that early introduction may not be tolerated and may increase the risk of
necrotizing enterocolitis. However, prolonged enteral fasting may diminish the functional
adaptation of the immature gastrointestinal tract and extend the need for parenteral
nutrition with its attendant infectious and metabolic risks. Early introduction of small
volumes of milk in the form of Trophic feeding, promote intestinal maturation, may enhance
feeding tolerance and decrease the time taken to reach full enteral feeding independently of
parenteral nutrition.
A Randomized Trial will be carried out over a period of 12 months in Department of
Neonatology of BSMMU. Sample size will be 50(25 in each group). Infants with gestation below
35 weeks, birth weight below the 10th percentile for gestational age, will be randomly
allocated by web-based randomization to commence enteral feeds "early," whose feeding will be
started from 24 to 48 hours of age or "late," whose feeding will be started from 48 to 72
hours of age. Gradually feeding will be increased. Rate of advancement of feeding will be
same for both groups. Primary outcomes will be time to achieve full enteral feeding sustained
for 72 hours. Statistical analyses will be performed by using Fisher Exact test and by
Student's t test for categorical data and quantitative data respectively. Logistic regression
analyses will be performed to determine the role of independent variable.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Weeks |
Eligibility |
Inclusion Criteria: - All growth restricted preterm Infants of both sexes with gestational age 35 weeks or less and birth weight below 10th percentile for gestational age Exclusion Criteria: - • Hemodynamically unstable critically ill neonates. - Newborn with severe perinatal asphyxia. - Newborn with polycythemia requiring exchange transfusion - Newborn with major congenital anomalies - Syndromic manifestations or chromosomal malformations - Suspected inborn errors of metabolism. - Any baby who will have proven sepsis with shock or necrotizing enterocolitis will be excluded and will be replaced by new one in same category as per protocol analysis. - Any baby who develop shock (due to sepsis, cardiogenic, hypovolemic etc.) will be excluded and will be replaced by new one in same category as per protocol analysis. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Association of feeding with weight gain pattern | Early achievement of acceptable weight gain 20-25 gram per day | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04062513 -
Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
|
N/A | |
Completed |
NCT03412578 -
Effect of Tactile/Kinaesthetic Massage Therapy on DXA Parameter of Preterm Infants
|
N/A | |
Completed |
NCT03166722 -
Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition
|
N/A | |
Enrolling by invitation |
NCT03212547 -
The Effect of a Neonatologist's Standardized Guidance Intervention on Preterm Infants With Relational Withdrawal.
|
N/A | |
Completed |
NCT03931902 -
The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates
|
N/A | |
Completed |
NCT03302000 -
Visual Stimulation of Preterm Infants
|
N/A | |
Completed |
NCT03731546 -
Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
|
N/A | |
Completed |
NCT03104946 -
To Research the Relation Between Neonatal Morbidities and Poor Outcome in Preterm Infants
|
N/A | |
Completed |
NCT03704012 -
Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)
|
N/A | |
Suspended |
NCT03220282 -
The Milk, Growth and Microbiota Study
|
N/A | |
Active, not recruiting |
NCT03232931 -
Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
|
N/A | |
Completed |
NCT03242057 -
Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA
|
N/A | |
Completed |
NCT04089540 -
New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates
|
N/A | |
Not yet recruiting |
NCT02528851 -
Cardiorespiratory Effects of "Higher" Versus "Equivalent" CPAP Upon Extubation From High EAP in Preterm Infants
|
N/A | |
Completed |
NCT01959737 -
Delivery Room Skin-to-skin Study
|
N/A | |
Completed |
NCT03700463 -
Executive Functions and Preterm Children in 3 to 4 Year Old
|
||
Completed |
NCT02811432 -
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
|
N/A | |
Completed |
NCT03728764 -
Growth and Safety of a Two-stage Feeding System in Preterm Infants
|
N/A | |
Completed |
NCT04382976 -
The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants
|
||
Completed |
NCT03748914 -
C-UCM and Cerebral Oxygenation and Perfusion
|
N/A |