Clinical trial NCT04812249: Effect of Co-morbidities on the Development of Oral Feeding Ability in Pre-term Infants
Official title: Effect of Co-morbidities on the Development of Oral Feeding Ability in Pre-term Infants: a Prospective Study at Neonatology Unit of Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Feeding; Difficult, Newborn
Pre-Term
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 160
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns whose gestational age of \< 37 weeks.

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.

Detailed description: It is widely acknowledged that pre-term infants frequently experience difficulties in attaining independent oral feeding, thus delaying the achievement of an adequate nutritional status and hospital discharge which - according to the American Academy of Pediatrics- requires the ability to feed exclusively by mouth(1-2) The development of oral feeding ability in pre-term infants is therefore a primary concern for neonatologists.

Because of the immaturity of their body functions and the occurrence of co-morbidities, pre-term infants generally require a period of enteral feeding before they acquire the coordinated sucking ability that allows sufficient milk intake for growth(3) Furthermore, infant sucking skills differ between bottle- and breastfeeding (4), and pre-term infants have been reported to show a weaker and less coordinated suck (5).

Few studies have investigated the timing and effect of co-morbidities on the achievement of independent oral skills. Jadcherla et al. (6) reported that infants born with a gestational age of \< 28 weeks showed a significant delay in attaining the transition to oral feeding, but it has also been found that the occurrence of morbidities negatively correlates with postmenstrual age at the time of achieving oral feeding skills (6),(7-8).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The mean post-menstrual age in weeks at the time of starting and achieving full oral feeding will be evaluated
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mostafa Shafeek
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.