Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02389478
Other study ID # FNF201421
Secondary ID
Status Completed
Phase N/A
First received February 8, 2015
Last updated November 9, 2015
Start date March 2015
Est. completion date October 2015

Study information

Verified date November 2015
Source Children's Hospital of Fudan University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to explore the effects of Oropharyngeal administration of colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the protect immune function of colostrum to very low birth weight infants, to improve the utilization of breast milk and reduce infection rates of very low birth weight infants.


Description:

The number of very low born weight infants increased every year.they are suffer from many questions.Recent studies have shown that Oropharyngeal administration of colostrum to very low birth weight infants can reduce the time reach full enteral nutrition .But there are no evidence support that it can promote infants' immune response. The hypothesis of the current study is that Oropharyngeal administration of colostrum to very low birth weight infants may increase the secretion of sIgA in urine and saliva.

The current study adopts randomized, double blind, controlled intervention trial, gives Oropharyngeal administration of colostrums to very low birth weight infants in intervention group and Oropharyngeal administration of Normal saline to control group. All indicators in this study are discrete traits, for sIgA、Lactoferrin number in Saliva and urine, number of CRP,time Begin oral feeding,time up to full enteral feeding, Person's chi-square tests were used for comparisons. For Blood culture results,The number of necrotizing enterocolitis (NEC) occurred, the investigators use Chi-square tests for comparisons between two groups. The study expects that Oropharyngeal administration of colostrum to very low birth weight infants can increase the secretion of sIgA in urine and saliva.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Month
Eligibility Inclusion Criteria:

1. Born weight=1500g

2. transferred to our hospital within 24 hours after birth

3. the mother can provide colostrum

4. parents of the infants agreed to participate in this study

Exclusion Criteria:

1. The infants suffering from life-threatening conditions ,such as severe heart disease,whose survival time are expected <30d

2. The infants suffering from any kinds of disease,which impact they take human milk by mouth.(such as gastrointestinal malformations, NEC, etc.)

3. human milk is contraindicated

- An infant whose mother :

- Is infected with the human immunodeficiency virus (HIV)

- Is taking antiretroviral medications

- Has untreated active tuberculosis

- Is infected with human T-cell lymphotropic virus type l or ll

- Is using or dependent on an illicit drug except if the breastmilk is medically indicated

- Is taking prescribed cancer chemotherapy agents contraindicated for breastfeeding

- Is receiving any medications contraindicated in breast feeding

- Is receiving diagnostic or therapeutic radioactive isotopes or exposure to radioactive materials (for as long as they are radioactive in the milk)

- An infant diagnosed with galactosemia, a rare genetic metabolic disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Procedure:
Oropharyngeal administration of colostrums
rubbing drops of colostrum inside a baby's cheeks using a sterile syringe
Oropharyngeal administration of Normal saline
rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Fudan University Fudan University

References & Publications (1)

Rodriguez NA, Meier PP, Groer MW, Zeller JM. Oropharyngeal administration of colostrum to extremely low birth weight infants: theoretical perspectives. J Perinatol. 2009 Jan;29(1):1-7. doi: 10.1038/jp.2008.130. Epub 2008 Sep 4. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in sIgA at 7 days in urine and saliva at baseline(first time baby in hospital) and at 7 days No
Primary Change from Baseline in lactoferrin at 7 days in urine and saliva at baseline(first time baby in hospital) and at 7 days No
Primary Change from Baseline in sIgA at 21 days in urine and saliva at baseline(first time baby in hospital) and at 21 days No
Primary Change from Baseline in lactoferrin at 21 days in urine and saliva at baseline(first time baby in hospital) and at 21 days No
Secondary The duration from admission to the start of oral feeding when the first time participants start bottle feeding by mouth(>5ml/once) participants will be followed for the duration of hospital stay, an expected average of 3 days No
Secondary The duration from the start of enteric feeding to full enteric feeding when the volume of milk participants take by mouth up to 140ml/kg/day participants will be followed for the duration of hospital stay, an expected average of 14 days No
Secondary The number of participants with necrotizing enterocolitis (NEC) participants will be followed for the duration of hospital stay, an expected average of 4 weeks No
See also
  Status Clinical Trial Phase
Completed NCT02913677 - Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants: N/A
Completed NCT02379728 - Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth N/A
Completed NCT01341236 - Near Infrared Spectroscopy (NIRS) and Superior Mesenteric Artery (SMA) Doppler Patterns as Predictor of Feeding Tolerance in Very Low Birth Weight (VLBW) IntraUterine Growth Restricted (IUGR) and NON IUGR Infants Phase 4
Completed NCT05217186 - Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
Completed NCT03082313 - Movement-based Infant Intervention N/A
Terminated NCT01430832 - Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
Terminated NCT02599545 - Testosterone and Cortisol Levels in Infants
Completed NCT02583776 - Continuous Glucose Monitoring and Preterm Infants Phase 4
Active, not recruiting NCT01809548 - Preterm Infants on Early Solid Foods N/A
Completed NCT01363167 - Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2 N/A
Completed NCT01193270 - Vitamin E for Extremely Preterm Infants Phase 1
Completed NCT02078687 - Growth, Risks of Allergy and Metabolic Syndrome in 6 Year Old Children Born Preterm Compared to Postdischarge Nutrition N/A
Completed NCT00760942 - Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants N/A
Completed NCT02280031 - Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial. Phase 2
Completed NCT01717625 - The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia Phase 2
Completed NCT00601081 - Human Milk Fortifier and Cytokine Profile N/A
Completed NCT00009646 - Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP) Phase 3
Completed NCT00579943 - Regulation of Cerebral Blood Flow in Very Low Birth Weight Infants N/A
Recruiting NCT02016638 - Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes N/A
Terminated NCT01799629 - Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial N/A