PreTerm Birth Clinical Trial
Official title:
Linear Growth and Neurobehavioural Outcome in Preterm Neonates (<34 Weeks) at 37 Weeks and 40 Weeks of Corrected Gestational Age : a Prospective Observational Study
This study will evaluate the association of linear growth on neurobehavioural outcome in preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.
Growth of the preterm infant has historically been defined as weight gain over time. As
weight gain and nutrition have been more extensively studied and their relationships with
neurodevelopmental outcomes have been established, other growth parameters and their
relationships to outcome need to be assessed.
Large multicenteric studies have demonstrated that poor postnatal weight gain has a negative
effect on neurodevelopment . However, the neurodevelopmental consequences of linear stunting
in this population were not assessed .Understanding this relationship is important because
organ growth and differentiation are more closely linked to lean body mass and thus linear
growth than to weight gain or fat mass alone. Moreover, weight gain and linear growth are
not always tightly linked and may be influenced by both nutritional and non nutritional
factors.
Linear growth represents lean body mass and protein accretion and also indexes organ growth
and development, including the brain. American Academy of Pediatrics (AAP) recommends that
preterm infants should grow similar to the fetus,but this guideline has been mostly applied
to weight gain. As already described, the ideal weight gain to optimize neurodevelopmental
outcomes has been studied extensively. However, ideal linear growth has yet to be defined.
Intrauterine linear-growth velocity is approximately 1 cm/wk,and therefore is the goal that
most neonatologists currently follow.Given the increasing evidence that linear-growth
suppression is associated with poorer cognitive outcomes,length may now be an important
anthropometric biomarker for later neurodevelopment. Research is needed to determine optimal
goals of linear growth for preterm infants so as to optimize later growth and
neurodevelopmental outcomes.
Recently the role of neurobehaviour has evaluated as early as at 37-40 weeks of CGA and is
being predicted as an useful adjunct to the 12-18 month full neurodevelopmental assessment
.Neurobehavioural assessment by tools like NAPI have been shown to correlate with BSID score
at 18 months of corrected gestational age in preterm neonates.This has tremendous
implications in terms of initiating an early rehabilitation /stimulation program for these
neonates..
There is insufficient data on Correlation of linear growth and neurological outcome in
preterm VLBW babies in India.With majority of VLBW neonates in India being SGA this assumes
critical significance as growth faltering is reported to continue as late as 24 months
postnatally.The linkage of linear growth faltering and poor neurodevelopmental outcome needs
to be detected early in the India population and corrective strategies need to be instituted
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
Completed |
NCT02993744 -
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
|
N/A | |
Active, not recruiting |
NCT02673216 -
Infection and Adverse Pregnancy Outcome
|
||
Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
Completed |
NCT01412931 -
Protein and Ultrasound Indicators of Preterm Birth
|
N/A | |
Completed |
NCT02606058 -
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
|
N/A | |
Terminated |
NCT03715530 -
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
|
N/A | |
Completed |
NCT00422526 -
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|
Phase 3 | |
Enrolling by invitation |
NCT04251260 -
Effectiveness of Positioning in Preterm Neonates
|
N/A | |
Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 | |
Recruiting |
NCT03638037 -
Correlation Between Maternal Vitamin D Level And Preterm Birth
|
||
Completed |
NCT02225353 -
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
|
Phase 2 | |
Recruiting |
NCT03992534 -
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
|
Phase 1 | |
Completed |
NCT03144141 -
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
|
N/A | |
Completed |
NCT05210985 -
Examination of the Relationship Between Home Affordances With Development
|
||
Completed |
NCT04811742 -
Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn
|
N/A |