NCT04812249

Brief Summary

The aim of this study is to investigate the effect of co-morbidities on the timing of the achievement of full oral feeding in a cohort of pre-term infants and to evaluate their mode of feeding and feeding status at the time of hospital discharge.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 18, 2021

Last Update Submit

March 23, 2021

Conditions

Feeding; Difficult, NewbornPre-Term

Outcome Measures

Primary Outcomes (1)

  • The mean post-menstrual age in weeks at the time of starting and achieving full oral feeding will be evaluated

    Statistical analysis will be made using SPSS version 12 software to assess the outcomes

    Baseline

Interventions

Clinical assessmentOTHER

Clinical assessment and follow up of oral feeding ability

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborns whose gestational age of \< 37 weeks.

You may qualify if:

  • A randomised sample of all newborns whose gestational age of \< 37 weeks .
  • infants who will be admitted to the NICU of Assiut University Children Hospital between 1 May and 31 October 2021.

You may not qualify if:

  • known congenital and/or chromosomal diseases.
  • death during hospitalisation, or transfer to another institution.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Dodrill P, Donovan T, Cleghorn G, McMahon S, Davies PS. Attainment of early feeding milestones in preterm neonates. J Perinatol. 2008 Aug;28(8):549-55. doi: 10.1038/jp.2008.56. Epub 2008 Jun 26.

    PMID: 18580883BACKGROUND

  • American Academy of Pediatrics Committee on Fetus and Newborn. Hospital discharge of the high-risk neonate. Pediatrics. 2008 Nov;122(5):1119-26. doi: 10.1542/peds.2008-2174.

    PMID: 18977994BACKGROUND

  • Maggio L, Costa S, Zecca C, Giordano L. Methods of enteral feeding in preterm infants. Early Hum Dev. 2012 May;88 Suppl 2:S31-3. doi: 10.1016/S0378-3782(12)70011-7.

    PMID: 22633510BACKGROUND

  • Lau C, Geddes D, Mizuno K, Schaal B. The development of oral feeding skills in infants. Int J Pediatr. 2012;2012:572341. doi: 10.1155/2012/572341. Epub 2012 Nov 5. No abstract available.

    PMID: 23193413BACKGROUND

  • Capilouto GJ, Cunningham T, Frederick E, Dupont-Versteegden E, Desai N, Butterfield TA. Comparison of tongue muscle characteristics of preterm and full term infants during nutritive and nonnutritive sucking. Infant Behav Dev. 2014 Aug;37(3):435-45. doi: 10.1016/j.infbeh.2014.05.010. Epub 2014 Jun 20.

    PMID: 24956503BACKGROUND

  • Jadcherla SR, Wang M, Vijayapal AS, Leuthner SR. Impact of prematurity and co-morbidities on feeding milestones in neonates: a retrospective study. J Perinatol. 2010 Mar;30(3):201-8. doi: 10.1038/jp.2009.149. Epub 2009 Oct 8.

    PMID: 19812589BACKGROUND

  • Van Nostrand SM, Bennett LN, Coraglio VJ, Guo R, Muraskas JK. Factors influencing independent oral feeding in preterm infants. J Neonatal Perinatal Med. 2015 May 18;8(1):15-21. doi: 10.3233/NPM-15814045.

    PMID: 25766199BACKGROUND

  • Hwang YS, Ma MC, Tseng YM, Tsai WH. Associations among perinatal factors and age of achievement of full oral feeding in very preterm infants. Pediatr Neonatol. 2013 Oct;54(5):309-14. doi: 10.1016/j.pedneo.2013.03.013. Epub 2013 May 7.

    PMID: 23660538BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Mostafa Shafeek

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mohammed Khalaf Ali

CONTACT

+201002424743mohamed.khalaf119911@gmail.com

Amira Shalaby

CONTACT

+201223958949shalaby406.as@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 23, 2021

Study Start

May 1, 2021

Primary Completion

October 31, 2021

Study Completion

December 31, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03