Premature Birth Clinical Trial
Official title:
Initial Nutritional Strategy and Stature-level Growth During the Neonatal Period of Children Born Moderately Premature: Cohort EPIPAGE 2
The growth and nutrition of premature infants during the neonatal period is a concern of
neonatology services; it impacts the child's health in the short and long term. The weight
deficit, but especially the weak growth of the cranial perimeter during the Neonatal period
is associated with an increased risk of long-term neuro-cognitive impairment.
The optimal nutritional strategy, during the neonatal period, of children born moderately
premature is not known.
The optimization of nutrition in premature children is therefore a topical issue in
neonatology.
Our project aims to evaluate the impact of an aggressive early nutritional strategy
characterized by optimized caloric and protein intakes on the stature-level growth of 2000
children born moderately premature GA from 30 WA (week of amenorrhea) to 32 WA + 6 days and
included in the national cohort of follow-up of children of small gestational ages.
Nutritional intake during the first week of life will be analyzed in tertile. Children will
be grouped according to their calorie and protein during the first week of life. The tertile
1 will represent the group of children with the lowest nutritional intake (called the
"nutrition not aggressive "), the tertile 3 will define the group of children presenting the
contributions highest nutritional levels (called the "aggressive nutrition" group).
The primary endpoint will be the z-score change in weight, height and head circumference
between birth and age (36 adjusted age WA) between the "nonaggressive nutrition" group and
the group. "Aggressive nutrition".
The benefits are for public health to harmonize neonatal care practices within a region and
to better understand the impact of nutritional strategies on long-term neuro-cognitive
development.
The growth and nutrition of premature infants during the neonatal period is a concern of
neonatology services; it impacts the child's health in the short and long term. The weight
deficit, but especially the weak growth of the cranial perimeter during the Neonatal period
is associated with an increased risk of long-term neuro-cognitive impairment.
The optimal nutritional strategy, during the neonatal period, of children born moderately
premature is not known.
The optimization of nutrition in premature children is therefore a topical issue in
neonatology.
Our project aims to evaluate the impact of an aggressive early nutritional strategy
characterized by optimized caloric and protein intakes on the stature-level growth of 2000
children born moderately premature GA from 30 WA to 32 WA + 6 days and included in the
national cohort of follow-up of children of small gestational ages.
Nutritional intake (calorie intake and total protein intake) during the first week of life
will be analyzed in tertile.
Children will be grouped according to their calorie and protein during the first week of
life. The tertile 1 will represent the group of children with the lowest nutritional intake
(called the "nutrition not aggressive "), the tertile 3 will define the group of children
presenting the contributions highest nutritional levels (called the "aggressive nutrition"
group).
The primary endpoint will be the z-score change in weight, height and head circumference
between birth and age (36 adjusted age WA) between the "nonaggressive nutrition" group and
the group. "Aggressive nutrition".
The benefits are for public health to harmonize neonatal care practices within a region and
to better understand the impact of nutritional strategies on long-term neuro-cognitive
development.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05048550 -
Babies in Glasses; a Feasibility Study.
|
N/A | |
| Active, not recruiting |
NCT03655639 -
Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
|
||
| Enrolling by invitation |
NCT05542108 -
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
|
N/A | |
| Completed |
NCT03680157 -
Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
|
||
| Completed |
NCT03337659 -
A Cluster Randomized Controlled Trial of FICare at 18 Months
|
N/A | |
| Completed |
NCT03649932 -
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
|
Phase 1 | |
| Completed |
NCT03251729 -
Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
|
Phase 4 | |
| Not yet recruiting |
NCT05039918 -
Neonatal Experience of Social Touch
|
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 | |
| Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
| Completed |
NCT02913495 -
Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
|
Phase 4 | |
| Completed |
NCT02952950 -
Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study
|
N/A | |
| Not yet recruiting |
NCT02880696 -
Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates
|
N/A | |
| Completed |
NCT02879799 -
Family Integrated Care (FICare) in Level II NICUs
|
N/A | |
| Completed |
NCT02661360 -
Effects of Swaddling on Infants During Feeding
|
N/A | |
| Completed |
NCT02743572 -
Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants
|
N/A | |
| Completed |
NCT01352234 -
Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
|
Phase 4 | |
| Completed |
NCT01163188 -
Social Adjustment and Quality of Life After Very Preterm Birth
|
N/A | |
| Terminated |
NCT00675753 -
Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families
|
N/A | |
| Completed |
NCT00271115 -
Kangaroo Holding and Maternal Stress
|
N/A |